How Device Identifiers (GTINs) Work

GTINs are assigned based on the GS1 standards, which require that a product must have a Unit of Measure (UOM) for a GTIN to be assigned. This ensures consistency and uniqueness in product identification.

The Unit of Measure is critical in defining how a product is quantified, which directly impacts GTIN assignment. If the device count is 1, GHX assumes it as an EA.

Issues such as incomplete product data or lack of necessary attributes can hinder GTIN assignment.

Multiple GTINs may be necessary when there are changes in product packaging, manufacturing locations, or significant alternations to the product’s master design record.

Manufacturer submissions to regulatory databases, such as the FDA, can often be inconsistent because there is no standardized format for attributes. As a result, manufacturers may provide data with varying levels of detail and clarity.

GHX relies on manufacturers to submit high-quality data to the FDA, but this is not always ensured. Issues such as ambiguous product descriptions and the absence of non-mandatory attribute data can further complicate the situation.