Unique Device Identification (UDI)?
A UDI is a unique numeric or alphanumeric code and consists of two parts:
A Device Identifier (DI): mandatory part for the unique identification of the medical device or IVD.
A Production Identifier (PI): variable part with manufacturing data.
Creating a UDI
Order GS1 article codes/GTINs
Assign a GS1 article code to each version or model in order to uniquely identify the product. Use the GTIN-13 for this purpose. Because the healthcare barcodes (GS1-128 and GS1 Data Matrix) have 14 positions, you manually add a leading zero. Or you can use indicator digits to identify packaging levels, in which case you also get 14 positions.
Adding manufacturing data
Depending on the requirements of the legislation; add production date, expiry date, batch/lot number or a serial number. Use Application Identifiers (AIs) for this purpose. In the case of software, a software version can be added.
Place UDI in text form and as a symbol on the product
In healthcare, the GS1-128 and the GS1 DataMatrix are the two permitted barcodes worldwide. The manufacturer of the medical device chooses which barcode needs to be on the product.
Help with UDI
Partners can help you create and print a UDI in barcode form. GS1 also works with partners who can help with consultancy or product data sharing.