Difference between GS1 128 and UDI
GS1-128 and GS1 UDI both involve standards for product identification, but they serve different purposes and are used in distinct contexts.
GS1-128:
- GS1-128 is a variant of the Code 128 barcode that is used specifically to encode data in the GS1 system.
- It is a linear or one-dimensional (1D) barcode that can hold extensive data, including serial numbers, expiration dates, and batch numbers, in addition to a Global Trade Item Number (GTIN).
- GS1-128 is commonly used for logistics and transportation, for items that are in the supply chain.
- It includes Application Identifiers (AIs) which define the meaning and the format of the data encoded in the barcode.
GS1 UDI (Unique Device Identification):
- GS1 UDI is a system established by regulatory bodies such as the FDA and the EU for the unique identification of medical devices.
- The UDI system requires each medical device to have a unique identifier in the form of a UDI-DI (Device Identifier), which is specific to a device model, and a UDI-PI (Production Identifier), which includes information like the lot or batch number, the serial number, and/or expiration date.
- The UDI is not a barcode itself, but rather a system of identification. The UDI can be encoded into various types of barcodes, including GS1-128, or into a two-dimensional (2D) barcode like the GS1 DataMatrix.
The Difference:
- The main difference is that GS1-128 is a type of barcode that can be used to encode various types of data including but not limited to UDI, whereas GS1 UDI is a broader regulatory requirement that specifies how medical devices must be identified.
- UDI requires the use of an identifier that meets certain regulatory standards, and while GS1-128 barcodes can be used to encode a UDI, they are not the only method for doing so.
- GS1 is one of the issuing agencies approved to assign codes that can be used in the UDI system, and GS1-128 is one of the standards that can be used to encode these identifiers.
In summary, GS1-128 is a type of barcode that can be used among other uses to implement the UDI regulatory requirements, whereas GS1 UDI refers to the set of regulatory requirements themselves, which dictate that medical devices must have a unique identifier. GS1 provides the standards for these identifiers that can be encoded into various types of barcodes, including GS1-128.
