For HCT/Ps that are regulated as a medical device, the Device Identifier Checker allows a user to parse the various elements of a single ISBT 128 Device Identifier (DI). This tool also interprets the Facility Identification Number and Product Description Code elements of the DI. Note: It is the user's responsibility to check that the correct data has been entered into the Device Identifier field and to verify the parsed elements.

Intended Audience:

This tool is intended for US tissue banks or cellular therapy facilities that produce human cells, tissues, and cellular and tissue-based products (HCT/P) that are regulated as medical devices by the FDA. The tool may also be of use to software developers and label vendors that provide solutions for these facilities.

Version 1.0: Device Identifier Checker – xlsx (613 kB)

For information on UDI, Medical Devices, and the UDI Generator, visit the page through the button below.

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