Figure 1. The generic GS1 Global Model Number The generic GS1 Global Model Number does not include any inherent data protection so it must be augmented with some form of check character validation if ...

This is a new identifier, and one not seen in the FDA regs and so not commonly used by GS1, and is described in the new rules as being: "The primary identifier of a device model. It is the DI assigned ...

GS1 Global Supply Chain Standards Support Patient Safety and Help Manufacturers Address New Regulation Requiring Unique Identification of Medical Devices Marketwired Tue, Dec 17, 2013, 10:59 AM ...

In addition, a new identifier was introduced by the EU Regulations: the Basic UDI-DI. GS1 has developed a new key (i.e. Global Model Number-GMN) to support the implementation of this requirement.

It requires all UDI numbers to be assigned by an FDA-accredited issuing agency. A UDI number generally must be applied to the medical device label, its packaging, and, in some cases, the device itself ...

Dive Insight: FDA passed its UDI rule in 2013. GS1, a FDA-accredited issuing agency for UDI, published its guideline to the implementation of the rule in September 2014. Since then, FDA has continued ...

GS1 UAE recently hosted an exclusive Healthcare User Group UDI Stream focused on accelerating the implementation of Unique Device Identification (UDI) for medical devices in the country. The event ...

The four Basic UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA. The structure of the Basic UDI-DI is an 18-character data string, with various parts of that string signifying the manufacturing ...

GS1 UAE recently hosted an exclusive Healthcare User Group UDI Stream focused on accelerating the implementation of Unique Device Identification (UDI) for medical devices in the country. The event ...