Symbol | Description | Meaning | Symbol Reference | Standard Title |
|---|---|---|---|---|
 | Catalog Number | Indicates the manufacturer's catalog number so that the medical device can be identified | symbol 5.1.6 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Manufacturer | Indicates the medical device legal manufacturer | symbol 5.1.1 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | EC Representative | Indicates the authorized representative in the European Community / European Union | symbol 5.1.2 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Swiss Representative | Authorized Representative in Switzerland | ISO 20417 Reference no. 6.1.2 d) | Medical devices — Information to be supplied by the manufacturer. |
 | UK Responsible Person | Indicates the UK Responsible Person | ISO 20417 Reference no. 6.1.2 d) | Medical devices — Information to be supplied by the manufacturer |
 | Lot Number | 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”. | symbol 5.1.5 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Serial Number | Indicates the manufacturer's serial number so that a specific medical device can be identified | symbol 5.1.7 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | UDI Carrier | Indicates a carrier that contains unique device identifier information | symbol 5.7.10 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Expiration Date | Indicates the date after which the medical device is not to be used | symbol 5.1.4 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Manufacturing Date | Indicates the date when the medical device was manufactured | symbol 5.1.3 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Temperature range to which device can be used | On device label and carton label: Indicates the temperature range at which device should be used | symbol 5.3.7 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Humidity limitation | Indicates the range of humidity to which the medical device can be safely exposed. | symbol 5.3.8 from ISO 15223-1 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied |
 | Sterilized with Gamma Radiation | Indicates a medical device that has been sterilized using irradiation | symbol 5.2.4 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Caution required when using device– Refer to IFU | Indicates that caution is necessary when operating the device. Refer to IFU before use. | symbol 5.4.4 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Consult IFU before using | Indicates the need for the user to consult the instructions for use | symbol 5.4.3 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Consult eIFU using given URL before using device | Indicates location of electronic IFU | symbol 5.4.3 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | For Prescription Use Only | Caution: Federal law restricts this device to sale by or on the order of a physician | 21 CFR 801.109 | n/a |
 | Device is not safe for use in a magnetic resonance environment | An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment | ASTM F2503 Reference no. Table 2, Symbol 7.3.3; 7.4.9.1; Fig. 9 | Standard Practice for Marking Medical Devices and other Items for safety in the Magnetic Resonance Environment |
 | Do Not Reuse | Indicates a medical device that is intended for one single use only NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”. | symbol 5.4.2 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Do Not Re-sterilize | Indicates a medical device that is not to be resterilized | symbol 5.2.6 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Item is a medical device | Indicates the item is a medical device | symbol 5.7.7 from ISO 15223-1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Single sterile barrier packaging system | Indicates a single sterile barrier system | symbol 5.2.11 from ISO 15223-1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Do not use if package is damaged | 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 | symbol 5.2.8 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | CE Mark Notified Body Number (BSI NL: 2797) | ‘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 | EU 2017-745 Article 20.1; MDR Annex V paragraph 1 | REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices |
 | Not manufactured with natural rubber/latex | 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. | symbol 5.4.5 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
 | Importer | Indicates the entity importing the medical device into the locale | symbol 5.1.8 from ISO 15223‑1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. |
KORU Medical Systems, Inc.
100 Corporate Drive
Mahwah, NJ 07430 USA
Tel: +1-800-624-9600
Fax: +1-845-469-5518
