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DEVICE IDENTIFIER CHECKER

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 (596 kB)

For information on ISBT 128 and UDI, visit the Medical Devices subject area using the button below.