Electronic Product Data FAQs

WHAT IS A UNIQUE DEVICE IDENTIFIER (UDI)?

A UDI is a unique numeric or alphanumeric code that consists of two parts: the device identifier (DI), and the production identifier (PI).

Device Identifier (DI)

The device identifier is a required fixed number that identifies the labeler and the specific version of the device.

Production Identifier (PI)

The production identifier is a conditional, variable portion of the UDI that identifies one or more of the following:

Lot or batch number within which the device was manufactured
Serial number
Expiration date
Manufacture date

WHY IS UNIQUE DEVICE IDENTIFICATION IMPORTANT?

In 2013, the FDA released a final rule creating a unique device identification system with the purpose of adequately identifying devices through distribution and use. Since then, many other countries and groups have established UDI rules designed to improve device traceability and supply chain efficiency. These global UDI rules establish industry standards for:

Readability requirements
A clearer date format
More permanent device marking
Universal data access

UDI rules require device labelers to include a UDI on device labels and packages, except in cases where an exception or alternative is allowed. Each UDI must be provided in plain text and a form that uses automatic identification and data capture (AIDC) technology—typically a barcode.

WHAT ARE THE KEY COMPONENTS OF THE FDA UDI RULE?

The FDA published its final rule in 2013 in the Federal Register establishing a system for UDIs and the GUDID. The FDA rule requires manufacturers selling into the US market to include UDIs in human readable and barcode formats on their device labels and packages and to submit product data to the GUDID available online. Certain combination packs/kits and devices licensed under the Public Health Service (PHS) also must comply with the UDI rule.

The FDA believes these requirements will:

Reduce medical errors.
Simplify the integration of device use information into data systems.
Provide for more rapid identification of medical devices with adverse events, more rapid development of solutions to reported problems, more efficient resolution of device recalls, and more focused and effective FDA safety communication.

WHY DOES ICU Medical INCLUDE A UDI ON ITS PACKAGING?

ICU Medical includes a UDI to comply with global device labeling regulations such as FDA’s final rule released in 2013 that established the UDI system to adequately identify devices through distribution and use.¹ The FDA final rule requires device labelers to include a UDI on device labels and packages, except where the rule allows for an exception or alternative. Each UDI must be provided in a plain text and barcode. The UDI must be directly marked on a device intended for more than one use and reprocessed before each use.

CAN CUSTOMERS AND DISTRIBUTORS CONTINUE TO USE THE CURRENT CATALOG NUMBERS FOR ORDERS?

Yes. ICU Medical’s ordering processes will remain unchanged if you prefer to order by catalog number.

If you are interested in using the DI (GTIN) for your electronic data interchange (EDI) ordering processes, contact your ICU Medical sales representative.

WILL MY INVOICES OR PACKING SLIPS LOOK DIFFERENT?

Yes. In addition to using the ICU Medical SKU number, ICU Medical has started enhancing invoices or packing slips to include both DI and PI information. Implementation timelines are ongoing and dependent on country/supply chain requirements.

HOW CAN CUSTOMERS OBTAIN ADDITIONAL UDI INFORMATION FOR SPECIFIC ICU Medical PRODUCTS?

Contact your ICU Medical sales representative for specific information, or visit AccessGUDID. Customers using the GDSN can become a recipient of ICU Medical product data. Your sales representative can submit a request for you, or you can submit one here

WHICH CLASSES OF MEDICAL DEVICES DOES ICU Medical MANUFACTURE?

ICU Medical produces all classes of medical devices. ICU Medical also manufactures products that are exempt from the FDA UDI regulation and other regulations, such as products for veterinary use.

WILL ICU Medical BE PROVIDING PRODUCT INFORMATION ONLINE?

Yes. Products sold in the US are already available in the FDA GUDID, which stores product information. Products sold in the UK will be available via the GDSN to approved recipients. Contact your ICU Medical sales representative for more information about how to become an approved recipient.

SHOULD I EXPECT ANY DISRUPTIONS WHILE SCANNING ICU Medical PRODUCTS AT THE POINT OF CARE AND AS PART OF MY SUPPLY CHAIN PROCESSES?

Generally, you will find the new ICU Medical labels will be enhanced with additional data and will continue to function in your scanning processes. Please reach out to ICU Medical if you happen to have an issue with new DI or PI (or the associated SKU and barcode) as a result of UDI or GDSN implementation.