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data-uw-rm-brl="false"> Greater Asia </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-in" data-uw-rm-brl="false"> India </a> </li> <li> <a class="country-link" href="https://www.bd.com/ja-jp" data-uw-rm-brl="false"> 日本 </a> </li> <li> <a class="country-link" href="https://www.bd.com/ko-kr" data-uw-rm-brl="false"> 대한민국 </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-sea" data-uw-rm-brl="false"> Southeast Asia </a> </li> </ul> </ul> </li> </ul> </div> </nav> </div> <div class="bd-header__navigation__right"> <ul class="bd-header__site" id="bd-header__site"> <li class="languages-tab"> <a href="#"> <img class="bd-header__globe" src="/content/dam/bd-assets/bd-com/en-us/icons/generic/flag/header-flag-icon-boosted-blue.svg" alt="header-flag-icon-boosted-blue.svg" data-trackable="true" data-aem-asset-id="4eea73e2-65eb-433b-922f-a583cd736924"/> <p class="bd-header__globe-label">Australia & New Zealand</p> <spa class="arraow"></spa> </a> <div class="languages"> <div class="pad"> <div class="row"> <div class="col-sm-4"> <div class="lang-heading" data-uw-rm-heading="level" role="heading" aria-level="2">North America</div> <ul class=" no-bull"> <li> <a class="country-link" href="https://www.bd.com/en-ca/" data-uw-rm-brl="false"> Canada (EN) </a> </li> <li> <a class="country-link" href="https://www.bd.com/fr-ca" data-uw-rm-brl="false"> Canada (FR) </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-us" data-uw-rm-brl="false"> United States </a> </li> </ul> <div class="lang-heading" data-uw-rm-heading="level" role="heading" aria-level="2">South America</div> <ul class=" no-bull"> <li> <a class="country-link" href="https://www.bd.com/es-latam" data-uw-rm-brl="false"> América Latina (ES) </a> </li> <li> <a class="country-link" href="https://www.bd.com/pt-latam" data-uw-rm-brl="false"> América Latina (PT) </a> </li> </ul> </div> <div class="col-sm-4"> <div class="lang-heading" data-uw-rm-heading="level" role="heading" aria-level="2">Europe</div> <ul class=" no-bull"> <li> <a class="country-link" href="https://www.bd.com/fr-be" data-uw-rm-brl="false"> Belgique </a> </li> <li> <a class="country-link" href="https://www.bd.com/nl-be" data-uw-rm-brl="false"> België </a> </li> <li> <a class="country-link" href="https://www.bd.com/cs-cz" data-uw-rm-brl="false"> Česká republika </a> </li> <li> <a class="country-link" href="https://www.bd.com/de-de" data-uw-rm-brl="false"> Deutschland </a> </li> <li> <a class="country-link" href="https://www.bd.com/es-es" data-uw-rm-brl="false"> España </a> </li> <li> <a class="country-link" href="https://www.bd.com/fr-fr" data-uw-rm-brl="false"> France </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-il" data-uw-rm-brl="false"> Israel </a> </li> <li> <a class="country-link" href="https://www.bd.com/it-it" data-uw-rm-brl="false"> Italia </a> </li> <li> <a class="country-link" href="https://www.bd.com/nl-nl" data-uw-rm-brl="false"> Nederland </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-no" data-uw-rm-brl="false"> Nordics </a> </li> <li> <a class="country-link" href="https://www.bd.com/de-at" data-uw-rm-brl="false"> Österreich </a> </li> <li> <a class="country-link" href="https://www.bd.com/pl-pl" data-uw-rm-brl="false"> Polska </a> </li> <li> <a class="country-link" href="https://www.bd.com/de-ch" data-uw-rm-brl="false"> Schweiz </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-uk" data-uw-rm-brl="false"> United Kingdom </a> </li> </ul> </div> <div class="col-sm-4"> <div class="lang-heading" data-uw-rm-heading="level" role="heading" aria-level="2">Middle East, North Africa, Turkey</div> <ul class=" no-bull"> <li> <a class="country-link" href="https://www.bd.com/en-menat" data-uw-rm-brl="false"> Middle East, North Africa, Turkey </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-za" data-uw-rm-brl="false"> South Africa </a> </li> </ul> <div class="lang-heading" data-uw-rm-heading="level" role="heading" aria-level="2">Asia Pacific</div> <ul class=" no-bull"> <li> <a class="country-link" href="https://www.bd.com/en-anz/" data-uw-rm-brl="false"> Australia & New Zealand </a> </li> <li> <a class="country-link" href="https://www.bd.com/zh-cn/" data-uw-rm-brl="false"> 中国 </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-ga" data-uw-rm-brl="false"> Greater Asia </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-in" data-uw-rm-brl="false"> India </a> </li> <li> <a class="country-link" href="https://www.bd.com/ja-jp" data-uw-rm-brl="false"> 日本 </a> </li> <li> <a class="country-link" href="https://www.bd.com/ko-kr" data-uw-rm-brl="false"> 대한민국 </a> </li> <li> <a class="country-link" href="https://www.bd.com/en-sea" data-uw-rm-brl="false"> Southeast Asia </a> </li> </ul> </div> </div> <a class="close" href="#" data-uw-rm-brl="false"> <div class="bd-header__close-icon"></div> </a> </div> </div> </li> </ul> <button class="bd-header__search-button" aria-label="global search"></button> </div> <div class="bd-algolia-globalsearch bd-algolia-instantsearch instantsearch hide"> <div class="instant-search-comp" data-cmp-is="algoliaInstantSearchComp" data-search-config="algoliasearch_" data-searchjson="{"instantSearch":{"searchResultPagePath":"/en-anz/search.html","searchbar":{"placeholderText":"Search"},"cloudAppId":"U5DV82OD2G","cloudQueryKey":"fdca0cbf53371709ba485864b987197a","productPagePath":"/en-anz/products-and-solutions/products/product-page"}}"> <div> <div class="instant-search-comp__searchbox-wrap"> </div> </div> </div> </div> <div id="bd-search" data-api="/en-anz/search"> <form id="bd-search-form" data-api="/content/experience-fragments/bd-com/ga/anz/en-anz/site/header/master/jcr:content/root/bd_header.suggestions.json" autocomplete="off"> <div id="bd-search-icon"></div> <input id="bd-global-search__text" class="form-control mr-sm-2" type="search" placeholder="Search" aria-label="Search"/> <div id="bd-close-icon"></div> <div id="bd-search__results_section" data-api="/content/experience-fragments/bd-com/ga/anz/en-anz/site/header/master/jcr:content/root/bd_header.search.json"></div> </form> <input hidden id="header__hidden-tabs-facets-data" value="{}"/> </div> </header> </div> </div> </div> </div> </div> <div class="bd-product-page-ef bd-container__hidden" id="product-overview-present">true</div> </div> <div class="container responsivegrid aem-GridColumn aem-GridColumn--default--12"> <div id="container-8137a2409b" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="bd-spotlight-new aem-GridColumn aem-GridColumn--default--12"> <div class="bd-spotlight__main-container position-relative"> <div class="spotlight-left-color"> </div> <div class="spotlight-right-color"></div> <section class="spotlight__content-container bd-spotlight__container bd-spotlight__container-primary "> <div class="bd-spotlight__container-left "> <div class="bd-spotlight__container-left-inner"> <div title="<h1>Distributors</h1>" class="bd-spotlight__container-v2-left-inner-heading bd-spotlight-heading-html"> <h1>Distributors</h1></div> <div class="bd-spotlight__container-left__description-left" title="<p>BD manufactures and sells a wide selection of products and services for the healthcare, consumer, life sciences and industrial markets. Most of our products are sold through distributors and wholesalers. </p> "><p>BD manufactures and sells a wide selection of products and services for the healthcare, consumer, life sciences and industrial markets. Most of our products are sold through distributors and wholesalers. </p> </div> </div> </div> <div class="bd-spotlight__container-right"> <div class="bd-spotlight__container-right-inner bd-spotlight__padding-left-image-video"> <div class="bd-spotlight__image-box"> <img data-trackable="true" alt="Background Image"/> </div> </div> </div> </section> </div> <div id="bd-global-funding-opportunities-tabs"></div> </div> <div class="bd-tabs tabs panelcontainer aem-GridColumn aem-GridColumn--default--12"><div class="bd-dropdown__placeholder" id="bd-tabs-placeholder"> <span class="bd-dropdown__placeholder-text"></span> </div> <div id="bd-tabs-ca5ed5cc55" class="cmp-tabs bd-tabs__container" data-cmp-is="tabs" data-cmp-data-layer="{"bd-tabs-ca5ed5cc55":{"shownItems":["bd-tabs-ca5ed5cc55-item-2ec224dbb5"],"@type":"bd-com/components/bd-tabs","repo:modifyDate":"2023-12-13T10:12:14Z"}}" data-placeholder-text="false"> <div class="grey-bg-color"> <ol role="tablist" class="cmp-tabs__tablist spotlight__content-container" aria-multiselectable="false"> <li role="tab" id="distributorlist" class="cmp-tabs__tabitem cmp-tabs__tab cmp-tabs__tab--active" aria-controls="distributorlist" tabindex="0" data-cmp-hook-tabs="tab"> Distributor List </li> <li role="tab" id="uniquedeviceidentifierudi" class="cmp-tabs__tabitem cmp-tabs__tab" aria-controls="uniquedeviceidentifierudi" tabindex="-1" data-cmp-hook-tabs="tab"> Unique Device Identifier (UDI) </li> </ol> </div> <div id="distributorlist" role="tabpanel" aria-labelledby="distributorlist" tabindex="-1" class="cmp-tabs__tabpanel cmp-tabs__tabpanel--active" data-cmp-hook-tabs="tabpanel"><div class="container responsivegrid"> <div id="container-2ec224dbb5" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="bd-container responsivegrid aem-GridColumn aem-GridColumn--default--12"> <div id="bd-container-e2fd9f5581" class="cmp-container bd-container__simple-image "> <div class="bd-algolia-instantsearch instantsearch bd-standalone-searchbar"> <div class="instant-search-comp" data-cmp-is="algoliaInstantSearchComp" data-search-config="algoliasearch_20231213101214901" data-searchjson="{"instantSearch":{"algoliaSearchContainerId":"algoliasearch_20231213101214901","enableSearchbar":"true","userIdType":"algoliaAnalytics","indices":[{"showStats":"true","noResultsFoundStatsMessage":"We couldn't find any results. Please try again later.","distributorsSearchButtonLabel":"Search","hitsPerPage":"10","indexName":"EN_ANZ_DISTRIBUTORS_PROD","statsMessage":"Browse All Distributors","category":"distributors","paginationType":"pagination","defaultTemplate":"/content/dam/bd-com/algolia-templates/algolia-hit-templates/jcr:content/data/distributors","distributorsSearchIconAlt":"Search","containerId":"index-1693900388662","sourceId":"index-1693900388662","template":"<div class=\"algolia-analytics\" data-insights-query-id=\"{{__queryID}}\" data-insights-object-id=\"{{objectID}}\" data-insights-position=\"{{__position}}\" data-cug=\"{{meta.cug}}\"><div> <div class=\"bd-product-search-card__wrapper\"> {{#distributor.website}} <a href=\"{{distributor.website}}\" target=\"_blank\"> {{/distributor.website}} {{#distributor.name}} <h4 class=\"bd-product-search-card__heading\" aria-label=\"Distributor: {{distributor.name}}\">{{distributor.name}}</h4> {{/distributor.name}} {{#distributor.website}} </a> {{/distributor.website}} <span class=\"border-line\"></span> {{#distributor.address}} <a href=\"{{distributor.mapLink}}\" aria-label=\"Location: {{distributor.address}}\" class=\"bd-product-search-card__mail\"> <img class=\"bd-product-search-card__phone-icon\" src=\"/etc.clientlibs/bd-com/clientlibs/clientlib-site/resources/image/location-blue.svg\" alt=\"\" /> {{distributor.address}} </a> {{/distributor.address}} <div> <img class=\"bd-product-search-card__phone-icon\" src=\"/etc.clientlibs/bd-com/clientlibs/clientlib-site/resources/image/icons/phone.svg\" alt=\"\" /> <div> {{#distributor.phones}} <a href=\"tel:{{.}}\" class=\"bd-product-search-card__phone\" aria-label=\"Telephone number: {{.}}\"> {{.}} </a> {{/distributor.phones}} </div> </div> <div> {{#distributor.fax}} <img class=\"bd-product-search-card__phone-icon\" src=\"/etc.clientlibs/bd-com/clientlibs/clientlib-site/resources/image/fax.svg\" alt=\"\" /> <a href=\"fax:{{distributor.fax}}\" class=\"bd-product-search-card__fax\" aria-label=\"Fax: {{distributor.fax}}\"> {{distributor.fax}} </a> {{/distributor.fax}} </div> <div> {{#distributor.email}} <img class=\"bd-product-search-card__phone-icon\" src=\"/etc.clientlibs/bd-com/clientlibs/clientlib-site/resources/image/icons/envelope-blue.svg\" alt=\"\" /> <a href=\"mailto:{{distributor.email}}\" class=\"bd-product-search-card__email\" aria-label=\"${E-Mail}: {{distributor.email}}\"> {{distributor.email}} </a> {{/distributor.email}} </div> </div></div></div>","templateHtmlShim":["<div class=\"algolia-analytics\" data-insights-query-id=\"","item.__queryID","\" data-insights-object-id=\"","item.objectID","\" data-insights-position=\"","item.__position","\" data-cug=\"","item.meta.cug","\"><div> <div class=\"bd-product-search-card__wrapper\"> ","item.#distributor.website"," <a href=\"","item.distributor.website","\" target=\"_blank\"> ","item.distributor.website","/ ","item.distributor.name","# <h4 class=\"bd-product-search-card__heading\" 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","item.distributor.fax","# <img class=\"bd-product-search-card__phone-icon\" src=\"/etc.clientlibs/bd-com/clientlibs/clientlib-site/resources/image/fax.svg\" alt=\"\" /> <a href=\"fax:","item.distributor.fax","\" class=\"bd-product-search-card__fax\" aria-label=\"Fax: ","item.distributor.fax","\"> ","item.distributor.fax"," </a> ","item.distributor.fax","/ </div> <div> ","item.distributor.email","# <img class=\"bd-product-search-card__phone-icon\" src=\"/etc.clientlibs/bd-com/clientlibs/clientlib-site/resources/image/icons/envelope-blue.svg\" alt=\"\" /> <a href=\"mailto:","item.distributor.email","\" class=\"bd-product-search-card__email\" aria-label=\"${E-Mail}: ","item.distributor.email","\"> ","item.distributor.email"," </a> ","item./distributor.email"," </div> </div></div></div>"],"filterExpression":"(catalogVersion:Online)","enableFilter":true}],"searchbar":{"placeholderText":"Search"},"cloudAppId":"U5DV82OD2G","cloudQueryKey":"fdca0cbf53371709ba485864b987197a","productPagePath":"/en-anz/products-and-solutions/products/product-page"}}"> <div class="bd-instantsearch"> <div> <div class="instant-search-comp__searchbox-wrap"> <div class="searchbox"> </div> </div> </div> <div id="queryRuleCustomData"></div> <div> <div class="row search"> <div class="search-results-tabs"> <div class="search-results-tab" id="index-1693900388662" data-index-name="EN_ANZ_DISTRIBUTORS_PROD"> <div class="row"> <div id="index-1693900388662-rules" class="rules-container"></div> <div class="instant-search-comp__main"> <div class="row "> <div class="col-md-6"> <div id="index-1693900388662-stats" class="stats-container mb-3"></div> </div> <div class="col-md-6 sort-by-container"> <div id="index-1693900388662-sort-by" class="sort-by-widget"></div> </div> </div> <div id="index-1693900388662-hits" data-indexname="EN_ANZ_DISTRIBUTORS_PROD" class="instant-search-comp__hits gridView"> </div> <div id="index-1693900388662-pagination" class="pagination-container "></div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="uniquedeviceidentifierudi" role="tabpanel" aria-labelledby="uniquedeviceidentifierudi" tabindex="-1" class="cmp-tabs__tabpanel" data-cmp-hook-tabs="tabpanel"><div class="container responsivegrid"> <div id="container-5cfba5ac97" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="bd-container responsivegrid aem-GridColumn aem-GridColumn--default--12"> <div id="bd-container-1b3e6f97d6" class="cmp-container bd-container__simple-image "> <div class="bd-container responsivegrid"> <div class="bd-container__background bd-container__background-image "> <div class="cmp-container cmp-container-responsive" id="bd-container-ffc67ac54e"> <div class="aem-Grid aem-Grid--12 aem-Grid--tablet--12 aem-Grid--default--12 aem-Grid--smallDesktop--12 aem-Grid--largeDesktop--12 aem-Grid--smallMobile--12 aem-Grid--mobile--12 "> <div class="bd-container responsivegrid bd-container__heading-width aem-GridColumn--offset--smallDesktop--0 aem-GridColumn--offset--largeDesktop--0 aem-GridColumn--default--none aem-GridColumn--tablet--3 aem-GridColumn--largeDesktop--none aem-GridColumn--offset--default--0 aem-GridColumn--mobile--hide aem-GridColumn--offset--mobile--0 aem-GridColumn--offset--tablet--0 aem-GridColumn--smallDesktop--none aem-GridColumn--smallMobile--12 aem-GridColumn--smallDesktop--3 aem-GridColumn--largeDesktop--3 aem-GridColumn--tablet--none aem-GridColumn aem-GridColumn--offset--smallMobile--0 aem-GridColumn--default--3 aem-GridColumn--mobile--12 aem-GridColumn--smallMobile--hide"> <div class="bd-container__background bd-container__background-image "> <div class="cmp-container cmp-container-default" id="bd-container-5b39a5df75"> <div class="aem-Grid aem-Grid--3 aem-Grid--tablet--3 aem-Grid--smallDesktop--3 aem-Grid--default--3 aem-Grid--largeDesktop--3 aem-Grid--smallMobile--3 aem-Grid--mobile--3 "> <div class="bd-product-page-heading aem-GridColumn--smallDesktop--3 aem-GridColumn--default--none aem-GridColumn--largeDesktop--3 aem-GridColumn--smallMobile--3 aem-GridColumn--tablet--3 aem-GridColumn aem-GridColumn--mobile--3 aem-GridColumn--default--3 aem-GridColumn--offset--default--0"><div></div> <div class="bd-sidebar-component__container"> <div class="component-heading">Unique Device Identifier (UDI)</div>  </div> </div> </div> </div> </div> </div> <div class="bd-container responsivegrid aem-GridColumn--offset--tablet--0 aem-GridColumn--tablet--none aem-GridColumn aem-GridColumn--tablet--9 aem-GridColumn--default--12"> <div class="bd-container__background bd-container__background-image "> <div class="cmp-container cmp-container-default" id="bd-container-f6629ad8f1"> <div class="aem-Grid aem-Grid--12 aem-Grid--tablet--9 aem-Grid--default--12 aem-Grid--smallDesktop--12 aem-Grid--largeDesktop--12 aem-Grid--smallMobile--12 aem-Grid--mobile--12 "> <div class="bd-container responsivegrid aem-GridColumn--offset--smallDesktop--0 aem-GridColumn--offset--largeDesktop--0 aem-GridColumn--default--none aem-GridColumn--largeDesktop--none aem-GridColumn--offset--default--0 aem-GridColumn--smallDesktop--6 aem-GridColumn--offset--mobile--0 aem-GridColumn--offset--tablet--0 aem-GridColumn--smallDesktop--none aem-GridColumn--smallMobile--12 aem-GridColumn--largeDesktop--6 aem-GridColumn--tablet--none aem-GridColumn--mobile--none aem-GridColumn aem-GridColumn--tablet--9 aem-GridColumn--offset--smallMobile--0 aem-GridColumn--smallMobile--none aem-GridColumn--default--6 aem-GridColumn--mobile--12"> <div class="bd-container__background bd-container__background-image "> <div class="cmp-container cmp-container-default" id="bd-container-c2a1a28386"> <div class="aem-Grid aem-Grid--6 aem-Grid--tablet--9 aem-Grid--smallDesktop--6 aem-Grid--default--6 aem-Grid--largeDesktop--6 aem-Grid--smallMobile--12 aem-Grid--mobile--12 "> <div class="text font-size-16 aem-GridColumn--offset--largeDesktop--0 aem-GridColumn--default--none aem-GridColumn--largeDesktop--none aem-GridColumn--offset--default--0 aem-GridColumn--smallDesktop--6 aem-GridColumn--offset--mobile--0 aem-GridColumn--offset--tablet--0 aem-GridColumn--smallMobile--12 aem-GridColumn--largeDesktop--6 aem-GridColumn--tablet--none aem-GridColumn--mobile--none aem-GridColumn aem-GridColumn--tablet--9 aem-GridColumn--offset--smallMobile--0 aem-GridColumn--smallMobile--none aem-GridColumn--default--6 aem-GridColumn--mobile--12"> <div data-cmp-data-layer="{"text-d5f646fbfa":{"@type":"bd-com/components/text","repo:modifyDate":"2024-04-04T15:09:31Z","xdm:text":"<h3><b>UDI compliance</b></h3>\r\n<p>On September 24, 2013, the U.S. Food and Drug Administration (FDA) released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier (UDI). The UDI system facilitates medical device identification, traceability and tracking through distribution and use.</p>\r\n<p>The UDI system consists of three core segments. The first is the UDI, which is a unique number assigned to the version or model of a device that is required on all packaging labeling of finished goods. The UDI must include a device identifier (DI) and may contain a production identifier (PI). UDIs appear on labels in both plain text format and a format readable by automatic identification data capture (AIDC) technology (e.g., a barcode). This identifier also includes production-specific information such as the product's lot or batch number, expiration date and manufacturing date when that information appears on the label. Additionally, the date format must read as &quot;YYYY-MM-DD&quot; on all human-readable text (which does not include barcode text).</p>\r\n<p>The second component is Direct Part Marking, which is a permanent UDI marking on the device. If a device will be used more than once and be reprocessed before each use, it must also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package.</p>\r\n<p>The third component is the Global Unique Device Identification Database (GUDID), which is a publicly searchable database administered by the FDA that serves as a reference catalogue for every device with an identifier.</p>\r\n<h3><b>UDI compliance timeline</b></h3>\r\n<p>The FDA defined a phased approach to compliance depending on the device's risk classification (reference the FDA UDI timeline chart).<br>\r\n</p>\r\n<p>BD requires that all of our suppliers implement and adhere to the FDA UDI timeline, promptly responding to queries and regular communication on UDI efforts.</p>\r\n<p>Visit <span class=\"underline\"><span class=\"primary-blue-font-color\"><b><a href=\"https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system\" target=\"_blank\" rel=\"noopener noreferrer\">Unique Device Identifier (UDI)</a></b></span></span> or <span class=\"underline\"><span class=\"primary-blue-font-color\"><b><a href=\"https://accessgudid.nlm.nih.gov/\" target=\"_blank\" rel=\"noopener noreferrer\">AccessGUDID</a></b></span></span> on the FDA website, or contact your BD representative for more information on the UDI system.</p>\r\n"}}" id="text-d5f646fbfa" class="cmp-text"> <h3><b>UDI compliance</b></h3> <p>On September 24, 2013, the U.S. Food and Drug Administration (FDA) released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier (UDI). The UDI system facilitates medical device identification, traceability and tracking through distribution and use.</p> <p>The UDI system consists of three core segments. The first is the UDI, which is a unique number assigned to the version or model of a device that is required on all packaging labeling of finished goods. The UDI must include a device identifier (DI) and may contain a production identifier (PI). UDIs appear on labels in both plain text format and a format readable by automatic identification data capture (AIDC) technology (e.g., a barcode). This identifier also includes production-specific information such as the product's lot or batch number, expiration date and manufacturing date when that information appears on the label. Additionally, the date format must read as "YYYY-MM-DD" on all human-readable text (which does not include barcode text).</p> <p>The second component is Direct Part Marking, which is a permanent UDI marking on the device. If a device will be used more than once and be reprocessed before each use, it must also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package.</p> <p>The third component is the Global Unique Device Identification Database (GUDID), which is a publicly searchable database administered by the FDA that serves as a reference catalogue for every device with an identifier.</p> <h3><b>UDI compliance timeline</b></h3> <p>The FDA defined a phased approach to compliance depending on the device's risk classification (reference the FDA UDI timeline chart).<br /> </p> <p>BD requires that all of our suppliers implement and adhere to the FDA UDI timeline, promptly responding to queries and regular communication on UDI efforts.</p> <p>Visit <span class="underline"><span class="primary-blue-font-color"><b><a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system" target="_blank" rel="noopener noreferrer">Unique Device Identifier (UDI)</a></b></span></span> or <span class="underline"><span class="primary-blue-font-color"><b><a href="https://accessgudid.nlm.nih.gov/" target="_blank" rel="noopener noreferrer">AccessGUDID</a></b></span></span> on the FDA website, or contact your BD representative for more information on the UDI system.</p> </div> </div> </div> </div> </div> </div> <div class="bd-container responsivegrid aem-GridColumn--offset--smallDesktop--0 aem-GridColumn--offset--largeDesktop--0 aem-GridColumn--default--none aem-GridColumn--tablet--3 aem-GridColumn--largeDesktop--none aem-GridColumn--offset--default--0 aem-GridColumn--smallDesktop--6 aem-GridColumn--offset--mobile--0 aem-GridColumn--offset--tablet--0 aem-GridColumn--smallDesktop--none aem-GridColumn--smallMobile--12 aem-GridColumn--largeDesktop--6 aem-GridColumn--tablet--none aem-GridColumn--mobile--none aem-GridColumn aem-GridColumn--offset--smallMobile--0 aem-GridColumn--smallMobile--none aem-GridColumn--default--6 aem-GridColumn--mobile--12"> <div class="bd-container__background bd-container__background-image "> <div class="cmp-container cmp-container-default" id="bd-container-4827d0ecc1"> <div class="aem-Grid aem-Grid--6 aem-Grid--tablet--3 aem-Grid--smallDesktop--6 aem-Grid--default--6 aem-Grid--largeDesktop--6 aem-Grid--smallMobile--12 aem-Grid--mobile--12 "> <div class="bd-modal-image aem-GridColumn--offset--tablet--0 aem-GridColumn--smallDesktop--3 aem-GridColumn--default--none aem-GridColumn--largeDesktop--3 aem-GridColumn--smallMobile--3 aem-GridColumn--tablet--3 aem-GridColumn--tablet--none aem-GridColumn aem-GridColumn--mobile--3 aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div></div> <div class="bd-modal-image__container"> <img id="bd-modal-image__img" src="/content/dam/bd-assets/bd-com/en-us/images/distributors/udi-timeline.png" alt="udi-timeline.png" data-trackable="true" data-aem-asset-id="ffda4674-d871-45b3-8dbb-c76f02118b99"/> <div class="bd-modal-image__label">FDA UDI TIMELINE</div>  <div id="bd-modal-image__modal" class="bd-modal-image__modal"> <span class="bd-modal-image__close-btn">×</span> <img class="bd-modal-image__modal-content" id="bd-modal-image__modal-img" alt="udi-timeline.png"/> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="bd-container responsivegrid bd-container__grey"> <div class="bd-container__background bd-container__background-image "> <div class="cmp-container cmp-container-responsive" id="bd-container-68c777fb24"> <div class="aem-Grid aem-Grid--12 aem-Grid--tablet--12 aem-Grid--default--12 aem-Grid--smallDesktop--12 aem-Grid--largeDesktop--12 aem-Grid--smallMobile--12 aem-Grid--mobile--12 "> <div class="bd-container responsivegrid bd-container__heading-width aem-GridColumn--offset--smallDesktop--0 aem-GridColumn--offset--largeDesktop--0 aem-GridColumn--default--none aem-GridColumn--tablet--3 aem-GridColumn--largeDesktop--none aem-GridColumn--offset--default--0 aem-GridColumn--offset--mobile--0 aem-GridColumn--offset--tablet--0 aem-GridColumn--smallDesktop--none aem-GridColumn--smallMobile--12 aem-GridColumn--smallDesktop--3 aem-GridColumn--largeDesktop--3 aem-GridColumn--tablet--none aem-GridColumn--mobile--none aem-GridColumn aem-GridColumn--offset--smallMobile--0 aem-GridColumn--smallMobile--none aem-GridColumn--default--3 aem-GridColumn--mobile--12"> <div id="bd-container-20504e9002" class="cmp-container bd-container__simple-image "> <div class="bd-product-page-heading"><div></div> <div class="bd-sidebar-component__container"> <div class="component-heading">Unique Device Identifier (UDI) FAQs</div>  </div> </div> </div> </div> <div class="bd-container responsivegrid bd-text__width aem-GridColumn--offset--smallDesktop--0 aem-GridColumn--offset--largeDesktop--0 aem-GridColumn--default--none aem-GridColumn--largeDesktop--none aem-GridColumn--smallDesktop--9 aem-GridColumn--offset--default--0 aem-GridColumn--offset--mobile--0 aem-GridColumn--offset--tablet--0 aem-GridColumn--smallDesktop--none aem-GridColumn--smallMobile--12 aem-GridColumn--tablet--none aem-GridColumn--default--9 aem-GridColumn--mobile--none aem-GridColumn aem-GridColumn--tablet--9 aem-GridColumn--largeDesktop--9 aem-GridColumn--offset--smallMobile--0 aem-GridColumn--smallMobile--none aem-GridColumn--mobile--12"> <div id="bd-container-f65f35ecd0" class="cmp-container bd-container__simple-image "> <div class="accordion panelcontainer bd-accordian-faq"> <div id="accordion-720f890561" class="cmp-accordion" data-cmp-is="accordion" data-cmp-data-layer="{"accordion-720f890561":{"shownItems":[],"@type":"bd-com/components/accordion","repo:modifyDate":"2024-04-04T15:17:22Z"}}" data-placeholder-text="false"> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-792587488f":{"@type":"bd-com/components/accordion/item","dc:title":"What is unique device identification?"}}" id="accordion-720f890561-item-792587488f"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-792587488f-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-792587488f-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> What is unique device identification? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-792587488f-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-792587488f-button"><div class="container responsivegrid"> <div id="container-792587488f" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-79b98a306a":{"@type":"bd-com/components/text","repo:modifyDate":"2023-12-13T10:12:15Z","xdm:text":"<p>In 2013, the U.S. Food and Drug Administration (FDA) released a <b><span class=\"underline\"><span class=\"primary-blue-font-color\"><a href=\"https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system\" target=\"_blank\">final rule</a></span> </span></b>establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers&nbsp;to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain text version and in a form that uses automatic identification and data capture (AIDC).&nbsp;technology. The UDI will also need to be directly marked on a device intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format consistent with international standards and international practice.</p>\r\n<p>A UDI is a unique numeric or alphanumeric code that consists of the following two parts:</p>\r\n<p>1.A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device</p>\r\n<p>2.A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following details when included on the label of a device:</p>\r\n<ul>\r\n<li>The lot or batch number a device was manufactured within</li>\r\n<li>The serial number of a specific device</li>\r\n<li>The expiration date of a specific device</li>\r\n<li>The date a specific device was manufactured on</li>\r\n<li>The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular- and tissue-based product (HCT/P) regulated as a device1</li>\r\n</ul>\r\n"}}" id="text-79b98a306a" class="cmp-text"> <p>In 2013, the U.S. Food and Drug Administration (FDA) released a <b><span class="underline"><span class="primary-blue-font-color"><a href="https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system" target="_blank" rel="noopener noreferrer">final rule</a></span> </span></b>establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain text version and in a form that uses automatic identification and data capture (AIDC). technology. The UDI will also need to be directly marked on a device intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format consistent with international standards and international practice.</p> <p>A UDI is a unique numeric or alphanumeric code that consists of the following two parts:</p> <p>1.A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device</p> <p>2.A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following details when included on the label of a device:</p> <ul><li>The lot or batch number a device was manufactured within</li><li>The serial number of a specific device</li><li>The expiration date of a specific device</li><li>The date a specific device was manufactured on</li><li>The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular- and tissue-based product (HCT/P) regulated as a device1</li></ul> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-84f1a81f3d":{"@type":"bd-com/components/accordion/item","dc:title":"Why did the FDA implement unique device identification?"}}" id="accordion-720f890561-item-84f1a81f3d"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-84f1a81f3d-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-84f1a81f3d-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Why did the FDA implement unique device identification? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-84f1a81f3d-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-84f1a81f3d-button"><div class="container responsivegrid"> <div id="container-84f1a81f3d" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-7214f85c92":{"@type":"bd-com/components/text","repo:modifyDate":"2023-12-13T10:12:15Z","xdm:text":"<p>This final rule will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule will reduce medical errors that result from the misidentification of a device or confusion concerning its appropriate use. The identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It will allow the FDA, healthcare providers and the industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby, gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.</p>\r\n"}}" id="text-7214f85c92" class="cmp-text"> <p>This final rule will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule will reduce medical errors that result from the misidentification of a device or confusion concerning its appropriate use. The identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It will allow the FDA, healthcare providers and the industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby, gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.</p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-8fa8361d1c":{"@type":"bd-com/components/accordion/item","dc:title":"Why is BD changing its packaging to include a UDI?"}}" id="accordion-720f890561-item-8fa8361d1c"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-8fa8361d1c-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-8fa8361d1c-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Why is BD changing its packaging to include a UDI? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-8fa8361d1c-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-8fa8361d1c-button"><div class="container responsivegrid"> <div id="container-8fa8361d1c" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-823dd17535":{"@type":"bd-com/components/text","repo:modifyDate":"2023-12-13T10:12:15Z","xdm:text":"<p>In 2013, the FDA released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The&nbsp;<u><b><span class=\"primary-blue-font-color\"><span class=\"underline\"><a href=\"https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system\" target=\"_blank\">final rule</a></span></span></b></u>&nbsp;requires&nbsp;device labelers&nbsp;to include a UDI on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain text version and in a form that uses&nbsp;automatic identification and data capture (AIDC)&nbsp;technology. The UDI is also required to be directly marked on a device intended for more than one use and intended to be reprocessed before each use.</p>\r\n"}}" id="text-823dd17535" class="cmp-text"> <p>In 2013, the FDA released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The <u><b><span class="primary-blue-font-color"><span class="underline"><a href="https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system" target="_blank" rel="noopener noreferrer">final rule</a></span></span></b></u> requires device labelers to include a UDI on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI is also required to be directly marked on a device intended for more than one use and intended to be reprocessed before each use.</p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-a01e0527e6":{"@type":"bd-com/components/accordion/item","dc:title":"Will BD discontinue the use of catalogue numbers?"}}" id="accordion-720f890561-item-a01e0527e6"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-a01e0527e6-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-a01e0527e6-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Will BD discontinue the use of catalogue numbers? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-a01e0527e6-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-a01e0527e6-button"><div class="bd-container responsivegrid"> <div id="bd-container-a01e0527e6" class="cmp-container bd-container__simple-image "> <div class="text font-size-16"> <div data-cmp-data-layer="{"text-ec66938b32":{"@type":"bd-com/components/text","repo:modifyDate":"2024-04-04T15:12:38Z","xdm:text":"<p>No, BD will continue to use&nbsp;catalogue numbers in addition to GS1 Global Trade Item Numbers (GTINs) for device identification.</p>\r\n"}}" id="text-ec66938b32" class="cmp-text"> <p>No, BD will continue to use catalogue numbers in addition to GS1 Global Trade Item Numbers (GTINs) for device identification.</p> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-2cdd2675a1":{"@type":"bd-com/components/accordion/item","dc:title":"Can customers and distributors continue to use the current BD catalogue numbers for orders?"}}" id="accordion-720f890561-item-2cdd2675a1"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-2cdd2675a1-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-2cdd2675a1-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Can customers and distributors continue to use the current BD catalogue numbers for orders? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-2cdd2675a1-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-2cdd2675a1-button"><div class="container responsivegrid"> <div id="container-2cdd2675a1" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-b6adfc1ae0":{"@type":"bd-com/components/text","repo:modifyDate":"2024-04-04T15:14:32Z","xdm:text":"<p>Yes. BD ordering processes will continue to utilise the current BD catalogue numbers―the ordering process will remain unchanged if you prefer to order by BD&nbsp;catalogue numbers.</p>\r\n<p>If you are interested in using the DI&nbsp;<i>(GTIN)</i>&nbsp;for your electronic data interchange (EDI) ordering processes, contact your BD representative.</p>\r\n"}}" id="text-b6adfc1ae0" class="cmp-text"> <p>Yes. BD ordering processes will continue to utilise the current BD catalogue numbers―the ordering process will remain unchanged if you prefer to order by BD catalogue numbers.</p> <p>If you are interested in using the DI <i>(GTIN)</i> for your electronic data interchange (EDI) ordering processes, contact your BD representative.</p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-174404d1be":{"@type":"bd-com/components/accordion/item","dc:title":"Will my invoices or packing slips look different?"}}" id="accordion-720f890561-item-174404d1be"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-174404d1be-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-174404d1be-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Will my invoices or packing slips look different? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-174404d1be-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-174404d1be-button"><div class="container responsivegrid"> <div id="container-174404d1be" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-25d6711b70":{"@type":"bd-com/components/text","repo:modifyDate":"2024-04-04T15:14:00Z","xdm:text":"<p>Yes. In addition to using the BD&nbsp;catalogue number, BD has started enhancing invoices or packing slips to include both DI and PI information.</p>\r\n"}}" id="text-25d6711b70" class="cmp-text"> <p>Yes. In addition to using the BD catalogue number, BD has started enhancing invoices or packing slips to include both DI and PI information.</p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-95d1fb2f1d":{"@type":"bd-com/components/accordion/item","dc:title":"How can customers obtain additional UDI information for specific BD products?"}}" id="accordion-720f890561-item-95d1fb2f1d"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-95d1fb2f1d-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-95d1fb2f1d-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> How can customers obtain additional UDI information for specific BD products? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-95d1fb2f1d-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-95d1fb2f1d-button"><div class="container responsivegrid"> <div id="container-95d1fb2f1d" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-cb96d944e0":{"@type":"bd-com/components/text","repo:modifyDate":"2023-12-13T10:12:15Z","xdm:text":"<p>Contact your BD representative for specific information or visit&nbsp;<span class=\"primary-blue-font-color\"><span class=\"underline\"><a href=\"https://accessgudid.nlm.nih.gov/\" target=\"_blank\"><u><b>AccessGUDID</b></u>.</a></span></span></p>\r\n"}}" id="text-cb96d944e0" class="cmp-text"> <p>Contact your BD representative for specific information or visit <span class="primary-blue-font-color"><span class="underline"><a href="https://accessgudid.nlm.nih.gov/" target="_blank" rel="noopener noreferrer"><u><b>AccessGUDID</b></u>.</a></span></span></p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-33f5173a1b":{"@type":"bd-com/components/accordion/item","dc:title":"Which classes of medical devices does BD manufacture"}}" id="accordion-720f890561-item-33f5173a1b"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-33f5173a1b-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-33f5173a1b-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Which classes of medical devices does BD manufacture </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-33f5173a1b-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-33f5173a1b-button"><div class="container responsivegrid"> <div id="container-33f5173a1b" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-08835331c9":{"@type":"bd-com/components/text","repo:modifyDate":"2023-12-13T10:12:15Z","xdm:text":"<p>BD produces all classes of medical devices. We also manufacture products that are exempt from the FDA UDI regulation, such as pharmaceutical products and research use only (RUO) products.</p>\r\n"}}" id="text-08835331c9" class="cmp-text"> <p>BD produces all classes of medical devices. We also manufacture products that are exempt from the FDA UDI regulation, such as pharmaceutical products and research use only (RUO) products.</p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-17feed5dd9":{"@type":"bd-com/components/accordion/item","dc:title":"Will BD be providing product information online?"}}" id="accordion-720f890561-item-17feed5dd9"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-17feed5dd9-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-17feed5dd9-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Will BD be providing product information online? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-17feed5dd9-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-17feed5dd9-button"><div class="container responsivegrid"> <div id="container-17feed5dd9" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-0fed4a9aa3":{"@type":"bd-com/components/text","repo:modifyDate":"2023-12-13T10:12:15Z","xdm:text":"<p>Yes. BD has already started the process of populating the FDA Global Unique Device Identification Database (GUDID), which is a repository for product information. BD Class III products are already in the GUDID. Additional products will be added to the GUDID on or before the FDA UDI timeline.</p>\r\n"}}" id="text-0fed4a9aa3" class="cmp-text"> <p>Yes. BD has already started the process of populating the FDA Global Unique Device Identification Database (GUDID), which is a repository for product information. BD Class III products are already in the GUDID. Additional products will be added to the GUDID on or before the FDA UDI timeline.</p> </div> </div> </div> </div> </div> </div> </div> <div class="cmp-accordion__item" data-cmp-hook-accordion="item" data-cmp-data-layer="{"accordion-720f890561-item-0f1818337e":{"@type":"bd-com/components/accordion/item","dc:title":"Should I expect any disruptions while scanning BD products at the point of care and as part of my supply chain processes?"}}" id="accordion-720f890561-item-0f1818337e"> <div class="cmp-accordion__header"> <button id="accordion-720f890561-item-0f1818337e-button" class="cmp-accordion__button" aria-controls="accordion-720f890561-item-0f1818337e-panel" data-cmp-hook-accordion="button"> <span class="cmp-accordion__title "> Should I expect any disruptions while scanning BD products at the point of care and as part of my supply chain processes? </span> <span class="cmp-accordion__icon"></span> </button> </div> <div data-cmp-hook-accordion="panel" id="accordion-720f890561-item-0f1818337e-panel" class="cmp-accordion__panel cmp-accordion__panel--hidden" role="region" aria-labelledby="accordion-720f890561-item-0f1818337e-button"><div class="container responsivegrid"> <div id="container-0f1818337e" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text font-size-16 aem-GridColumn aem-GridColumn--default--12"> <div data-cmp-data-layer="{"text-207739192d":{"@type":"bd-com/components/text","repo:modifyDate":"2024-04-04T15:13:21Z","xdm:text":"<p>Generally, you will find that new BD labels will be enhanced with additional data and will continue to function in your scanning processes. In the event that a DI or PI&nbsp;<i>(and the associated catalogue number and barcode)</i>&nbsp;change as result of BD UDI implementation, you will be notified.</p>\r\n"}}" id="text-207739192d" class="cmp-text"> <p>Generally, you will find that new BD labels will be enhanced with additional data and will continue to function in your scanning processes. In the event that a DI or PI <i>(and the associated catalogue number and barcode)</i> change as result of BD UDI implementation, you will be notified.</p> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="bd-experiencefragment experiencefragment aem-GridColumn aem-GridColumn--default--12"><div class="bd-experience-fragment__container cmp-experiencefragment cmp-experiencefragment--footer"><div class="xfpage page basicpage"> <div id="container-4381a1d00d" class="cmp-container"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="bd-footer aem-GridColumn aem-GridColumn--default--12"><footer class="bd-footer"> <section class="position-relative"> <div class="spotlight-left-color"></div> <div class="spotlight-right-color"></div> <div class="bd-spotlight__container spotlight__content-container"> <div class="bd-spotlight__container-left"> <div class="bd-spotlight__container-left-inner"> <div class="bd-footer__bottom-right bd-footer__left-inner-content"> <ul class="bd-footer__bottom--right-socialicon"> <li class="d-block-lg">Follow us</li> <li> <ul> <li> <a href="https://www.linkedin.com/company/bd1?trk=biz-companies-cym" target="_blank"><img src="/content/dam/bd-assets/bd-com/en-us/icons/generic/linkedin/linkedin-black.svg" alt="Linked In" title="Linked In" data-trackable="true" data-aem-asset-id="71d25986-c09c-46e9-b225-5747cc0b66e6"/></a> </li> <li> <a href="https://www.facebook.com/BectonDickinsonandCo?ref=bookmarks" target="_blank"><img src="/content/dam/bd-assets/bd-com/en-us/icons/generic/facebook/fb-black.svg" alt="Facebook" title="Facebook" data-trackable="true" data-aem-asset-id="99026a03-1b33-4f14-9f99-a46a2726a860"/></a> </li> <li> <a href="https://twitter.com/BDandCo" target="_blank"><img src="/content/dam/bd-assets/bd-com/en-us/icons/generic/x/X_Logo.svg" alt="Twitter" title="Twitter" data-trackable="true" data-aem-asset-id="e9af0550-b0f0-4330-b4af-5166487ed8ca"/></a> </li> <li> <a href="https://www.youtube.com/channel/UCPGmutY43EjP_3ijOugNGnA" target="_blank"><img src="/content/dam/bd-assets/bd-com/en-us/icons/generic/youtube/youtube-black.svg" alt="Youtube" title="Youtube" data-trackable="true" data-aem-asset-id="49d4f5b6-13f9-4e6e-8f50-f7e060632667"/></a> </li> </ul> </li> </ul> </div> </div> </div> <div class="bd-spotlight__container-center d-block-lg"> <div class="bd-spotlight__container-center-inner"></div> </div> <div class="bd-spotlight__container-right spotlightCarousel-block"> <div class="bd-spotlight__container-right-inner"> <div class="spotlightCarousel"> <div class="spotlightCarousel-item"> <div class="spotlightCarousel-item__content"> <div class="spotlightCarousel-item__content-title"> Quick Links </div> <div class="spotlightCarousel-item__content-list-cnt"> <ul class="spotlightCarousel-item__content-list"> <li> <a target="_self" href="https://jobs.bd.com">Careers</a> </li> <li> <a target="_self" href="https://www.bd.com/en-us/about-bd/cybersecurity?lastUpdate=all-dates">Cybersecurity</a> </li> <li> <a target="_self" href="https://eifu.bd.com">Electronic Instructions for Use</a> </li> </ul> <ul class="spotlightCarousel-item__content-list"> <li> <a target="_self" href="https://investors.bd.com">Investors</a> </li> <li> <a target="_self" href="/en-anz/about-bd/esg?activetab=4">Inclusion, Diversity & Equity</a> </li> <li> <a target="_self" href="/en-anz/search?tab=literature">Literature</a> </li> </ul> <ul class="spotlightCarousel-item__content-list spotlightCarousel-item__content-list-col3"> <li> <a target="_self" href="/en-anz/about-bd/news-and-media">News, Media and Blogs</a> </li> <li> <a target="_self" href="/en-anz/about-bd/our-company">Our Company</a> </li> <li> <a target="_self" href="/en-anz/about-bd/our-company?activetab=3">Ethics and Compliance</a> </li> <li> <a target="_self" href="/en-anz/support">Support</a> </li> </ul> </div> </div> </div> </div> </div> </div> </div> <section class="bd-footer__bottom spotlight__content-container"> <div class="bd-footer__bottom-wrapper"> <div class="bd-footer__bottom-left"> <ul class="bd-footer__bottom-left-item"> <li><a href="/en-anz/support/contact-us">Contact us</a></li> <li> <a href="javascript:void(0)" onclick="event.preventDefault(); OneTrust.ToggleInfoDisplay();">Cookie Preferences</a> </li> <li><a href="/en-anz/about-bd/policies/privacy-policy-statement">Privacy</a></li> <li><a href="/en-anz/about-bd/policies/terms-of-use">Terms of Use</a></li> <li><a href="/en-anz/support/contact-us">Website Accessibility</a></li> </ul> </div> <div class="bd-footer__description"> <a href="/en-anz"><img src="/content/dam/bd-assets/bd-com/en-us/logos/bd/bd-logo-white.png" alt="BD_tag_en_1-Color_Reverse_RGB_TransparentBurst" title="BD_tag_en_1-Color_Reverse_RGB_TransparentBurst" data-trackable="true" data-aem-asset-id="1210f09a-d829-45a6-bf47-c39d8315a81f"/></a> <div><p>© 2025 BD. 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