Unique Device Identification (UDI) Labeling

About UDI

Many organizations within the healthcare industry face challenges ensuring their barcode labeling systems are compliant with various regulations.

The Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI), which is comprised of a unique numeric or alphanumeric code that is used to mark and identify medical devices within the supply chain.

As a result, all implantable, life-supporting/life-sustaining medical devices must bear a UDI label. Implementing UDI promises to reduce medical errors, simplify integration of data systems, and provide more rapid solutions to problems.

Full compliance with UDI includes three components:

• Including the UDI in all applicable systems and procedures, including quality systems, medical device reporting, and corrections & removals
• Accurate labeling of devices  and packaging including all specified information
• Loading the Device Identifier (DI), along with all associated information, into the Global Unique Device Identification Database (GUDID)

UDI label sample