23 Sep UDI Barcoding
Unique Device Identifier (UDI) Barcoding
The second stage of compliance for UDI barcoding is on the horizon. On September 24, 2015 all labels and packages of implantable, life-supporting and life sustaining devices must bear a UDI. Are you compliant with new UDI regulations?
A UDI comprises of two parts:
- A device identifier (DI) which is a unique alphanumeric or numeric code, that is specific to a device version or model.
- A Production Identifier (PI) which is an alphanumeric or numeric code, that identifies the production information for a device and may include the following information:
- Batch Number
- Serial Number
- Expiration Date
- Date of Manufacture
- For a human cell, tissue or cellular or tissue-based product (HCT/P) regulated as a device, the distinct identification code that allows the manufacturer to associate the HCT/P to the donor.
The UDI must appear in both plain text format and also in a machine readable format. Below we can examine a fictitious sample medical device label which displays the GUDID elements. In the image below the plain text format can be seen along with a 1D barcode which is required for machine-readable format.
As part of the UDI system the FDA have introduced a Global Unique Device Identification Database (GUDID) http://accessgudid.nlm.nih.gov/ . The system contains Device Identification information submitted by device companies to the FDA. The GUDID only contains the Device Identifier (DI), which serves as the primary key to obtain information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but GUDID data indicates which Production Identifiers are on the label.
For more information contact System Label today to understand how we can assist you with the printing of