Symbols Glossary :: KORU Medical Systems (KRMD)

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class="glossary-table"> <table border="2"> <thead> <tr style="background-color: #c1c1c1;"> <td style="width: 211.699px;"> <p><strong>Symbol:</strong></p> </td> <td style="width: 177.041px;"> <p><strong>Description:</strong></p> </td> <td style="width: 194.619px;"> <p><strong>Meaning:</strong></p> </td> <td style="width: 190.381px;"> <p><strong>Symbol Reference</strong></p> </td> <td style="width: 314.053px;"> <p><strong>Standard Title</strong></p> </td> </tr> </thead> <tbody> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/Catalog-Number-ISO_15223-1.jpg" alt="" width="150" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Catalog Number</p> </td> <td style="width: 194.619px;"> <p>Indicates the manufacturer's catalog number so that the medical device can be identified</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.6 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/Manufacturer-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Manufacturer</p> </td> <td style="width: 194.619px;"> <p>Indicates the medical device legal manufacturer</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.1 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/EC_Representative-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>EC Representative</p> </td> <td style="width: 194.619px;"> <p>Indicates the authorized representative in the European Community / European Union</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.2 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/CH_Rep-ISO_20417.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Swiss Representative</p> </td> <td style="width: 194.619px;"> <p>Authorized Representative in Switzerland</p> </td> <td style="width: 190.381px;"> <p>ISO 20417 Reference no. 6.1.2 d)</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Information to be supplied by the manufacturer</p> <p> </p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/UK_Rep-ISO_20417.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>UK Responsible Person</p> </td> <td style="width: 194.619px;"> <p>Indicates the UK Responsible Person</p> </td> <td style="width: 190.381px;"> <p>ISO 20417 Reference no. 6.1.2 d)</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Information to be supplied by the manufacturer </p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/LOT-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Lot Number</p> </td> <td style="width: 194.619px;"> <p>Indicates the manufacturer's batch code so that the batch or lot can be identified. Synonyms for “batch code” are “lot number”, “lot code” and “batch number”.</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.5 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/SN-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Serial Number</p> </td> <td style="width: 194.619px;"> <p>Indicates the manufacturer's serial number so that a specific medical device can be identified</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.7 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/UDI-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>UDI Carrier</p> </td> <td style="width: 194.619px;"> <p>Indicates a carrier that contains unique device identifier information</p> </td> <td style="width: 190.381px;"> <p>symbol 5.7.10 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/EXP-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Expiration Date</p> </td> <td style="width: 194.619px;"> <p>Indicates the date after which the medical device is not to be used</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.4 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/ManufactureDt-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Manufacturing Date</p> </td> <td style="width: 194.619px;"> <p>Indicates the date when the medical device was manufactured</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.3 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/TempRange-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Temperature range to which device can be exposed</p> </td> <td style="width: 194.619px;"> <p><br>Indicates the temperature limits to which the medical device can be safely exposed</p> <p> </p> </td> <td style="width: 190.381px;"> <p>symbol 5.3.7 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/SterileR-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Sterilized with Gamma Radiation</p> </td> <td style="width: 194.619px;"> <p>Indicates a medical device that has been sterilized using irradiation</p> </td> <td style="width: 190.381px;"> <p>symbol 5.2.4 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/Caution-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Caution required when using device– Refer to IFU</p> </td> <td style="width: 194.619px;"> <p>Indicates that caution is necessary when operating the device. Refer to IFU before use.</p> </td> <td style="width: 190.381px;"> <p>symbol 5.4.4 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/ConsultIFU-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Consult IFU before using</p> </td> <td style="width: 194.619px;"> <p>Indicates the need for the user to consult the instructions for use</p> </td> <td style="width: 190.381px;"> <p>symbol 5.4.3 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/ConsultEIFU-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Consult eIFU using given URL before using device</p> </td> <td style="width: 194.619px;"> <p>Indicates location of electronic IFU</p> </td> <td style="width: 190.381px;"> <p>symbol 5.4.3 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/RXOnly-21_CFR_801.109.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>For Prescription Use Only</p> </td> <td style="width: 194.619px;"> <p>Caution: Federal law restricts this device to sale by or on the order of a physician</p> </td> <td style="width: 190.381px;"> <p>21 CFR 801.109</p> </td> <td style="width: 314.053px;"> <p>n/a</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/MR-ASTM_F2503.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Device is not safe for use in a magnetic radiation environment</p> </td> <td style="width: 194.619px;"> <p>An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment</p> </td> <td style="width: 190.381px;"> <p>ASTM F2503 Reference no. Table 2, Symbol 7.3.3;<br>7.4.9.1; Fig. 9</p> </td> <td style="width: 314.053px;"> <p>Standard Practice for Marking Medical Devices and other Items for safety in the Magnetic Resonance Environment</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/DoNotReuse-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Do Not Reuse</p> </td> <td style="width: 194.619px;"> <p><br>Indicates a medical device that is intended for one single use only<br>NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”.</p> </td> <td style="width: 190.381px;"> <p>symbol 5.4.2  from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/DoNotResterilize-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Do Not Re-sterilize</p> </td> <td style="width: 194.619px;"> <p>Indicates a medical device that is not to be resterilized</p> </td> <td style="width: 190.381px;"> <p>symbol 5.2.6 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/MD-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Item is a medical device</p> </td> <td style="width: 194.619px;"> <p>Indicates the item is a medical device</p> </td> <td style="width: 190.381px;"> <p>symbol 5.7.7 from ISO 15223-1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/SingleSterileBarrier-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Single sterile barrier packaging system</p> </td> <td style="width: 194.619px;"> <p>Indicates a single sterile barrier system</p> </td> <td style="width: 190.381px;"> <p>symbol 5.2.11 from ISO 15223-1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/DamagedPackage-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Do not use if package is damaged</p> </td> <td style="width: 194.619px;"> <p><br>Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information</p> </td> <td style="width: 190.381px;"> <p>symbol 5.2.8 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/CEMark-EU_2017-745.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>CE Mark</p> <p>Notified Body Number (BSI NL: 2797)</p> </td> <td style="width: 194.619px;"> <p>‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the applicable regulation providing for its affixing</p> </td> <td style="width: 190.381px;"> <p>EU 2017-745 Article 20.1; MDR Annex V paragraph 1</p> </td> <td style="width: 314.053px;"> <p>REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/NoLatex-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Not manufactured with natural rubber/latex</p> </td> <td style="width: 194.619px;"> <p>Indicates  that the device has not been manufactured with dry natural rubber or natural rubber latex as a material of construction within the medical device itself or its packaging.</p> </td> <td style="width: 190.381px;"> <p>symbol  5.4.5  from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> <tr> <td style="width: 211.699px;"><img src="https://d1io3yog0oux5.cloudfront.net/_ce3be4c5be65318bda530b7950568f2c/korumedical/files/pages/korumedical/db/482/description/Importer-ISO_15223-1.jpg" width="150" alt="" style="display: block; margin-left: auto; margin-right: auto;"></td> <td style="width: 177.041px;"> <p>Importer</p> </td> <td style="width: 194.619px;"> <p>Indicates the entity importing the medical device into the locale</p> </td> <td style="width: 190.381px;"> <p>symbol 5.1.8 from ISO 15223‑1</p> </td> <td style="width: 314.053px;"> <p>Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.</p> </td> </tr> </tbody> </table> <p></p> </div> </div> </div> </div> </div> </div> </div> </div><footer id="footer"> <div class="footer-main"> <div class="container"> <div class="row"> <div class="col-sm-12 col-md-4"> <div class="footer-header"> <div class="footer-logo"> <a href="/"> <img src="https://d1io3yog0oux5.cloudfront.net/_0eb9eb7c5a5cc42bae42cbb4821f1b24/korumedical/files/theme/images/footer-logo-white@1x.svg" width="199" height="56" alt="KORU Medical Systems"> </a> </div> <p>KORU Medical Systems<br> 100 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Symbols Glossary :: KORU Medical Systems (KRMD)