This section consists of material that pertains to facilities that receive HCT/P medical devices.
Medical Device Receiving Facilities
The following illustration depicts an example HCT/P medical device label with an ISBT 128 UDI (the abbreviations are defined in the table below):
|
Item |
Recommended Abbreviation(s) |
|
Donation Identification Number |
DIN |
|
Product Code |
Prod Code or PC |
|
Pack Number or Serial Number |
Pack or SN |
|
Expiration Date |
Exp or Exp Date |
|
Manufacturing or Production Date |
Mnf Date or Prod Date |
|
Lot Number |
Lot No. or LN |
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The following illustration depicts an example ISBT 128 UDI that would appear on the product label and provides a breakdown of the UDI elements:
How do I parse the ISBT 128 UDI to extract the data items required by 45 CFR Part 170? See Section 5 of the “ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128” document (ST-011).
For more UDI-related information and illustrations, see the “ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128” document (ST-011). This document—along with other documents that pertain to medical devices—can be found on the Medical Devices – Documents page.