Global Site
Australia
Canada
中国 (China)
France
Deutschland (Germany)
India
日本 (Japan)
España (Spain)
UK
USA
Belgie (Belgium)
Brasil (Brazil)
Denmark 
Ireland
Italia (Italy)
México
Nederland (Netherlands)
Österreich (Austria)
Portugal
Sverige (Sweden)
Schweiz (Switzerland)
UAE
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.
Packaging Levels
Each/Primary/Point of Use
The packaging level closest to the product.Carton/Secondary/Intermediate
The packaging level containing one or more primary levels of the same product.Case/Outer/Shipper
The 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
GTINs
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).
