CLEAR IDENTIFICATION AND SCANNING
Product packaging that is UDI-compliant, makes it easy to track a product from the manufacturing site to its use at a patient’s bedside. Barcodes in linear and 2D formats allow for easy scanning at most packaging levels.
Current UDI Compliance
The image illustrates ICU Medical’s current UDI compliance.
Each/Primary/Point of UseThe packaging level closest to the product.
Carton/Secondary/IntermediateThe packaging level containing one or more primary levels of the same product.
Case/Outer/ShipperThe shipping level of packaging.
UDI Compliant Labels
ICU Medical meets global UDI Compliance standards on our labels in 3 ways:
- Standardized date format in YYYY-MM-DD
- Device identification that includes:
- GTIN – a fixed, product identifier
- Variable production identifiers
- Plain text and barcode formats
Global Trade Identification Numbers (GTINs) are a crucial part of the UDI system. These unique 14-digit numbers are required on device labeling and packaging (except in special cases of exemption). The GTIN appears in the first portion of the Device Identifier (DI) (for example: (01) 12345678912345).