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.
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.