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.