Check UDI duties without treating a barcode as proof

Map the identifier to the actual package

Identify the device identifier, or DI, and the applicable production identifier elements, or PI, such as lot, serial number, manufacturing date or expiration date. Which PI elements apply depends on the actual label and duties. Check the labeler and the issuing-agency system; a retailer stock number or ordinary UPC is not automatically sufficient.

Review the human-readable and machine-readable presentations against the same assigned data. Reconcile each applicable package level, kit or accessory with its identity and records. Check any required date format and direct marking separately. A scanner returning some text proves decoding only, not correct assignment, applicability, data submission or legal compliance.

Keep exceptions and database duties separate

Determine whether GUDID submission duties apply and which party maintains the device record. Retain the applicable DI record and change-control decision. A database entry does not verify every PI on a manufactured unit. A UDI exception should identify the exact provision, factual basis and scope; do not mark it satisfied just because another brand omits UDI.

For example, a distributor may replace an outer label while retaining the original device inside. Assess whether the change affects labeler responsibility, identifier assignment, packaging levels or submitted device data before reusing the original code. Review reusable devices and direct marking based on their actual use and reprocessing circumstances, not the outer carton alone.

Use this checklist as an evidence log

The UDI checkbox in the product pre-check means that you declared UDI evidence or a documented exception. This tool neither decodes barcodes nor validates GUDID records. Keep assignment, artwork, scanning checks and exception rationale outside the checkbox, and repeat the review after labeler, model or packaging changes.

Keep evidence and decisions separate

Keep the original evidence and the released device version together. When a source or fact is uncertain, record the open question instead of converting it into a pass. Official database references and this checklist do not substitute for a device-specific decision.

Official starting points for this topic

• FDA UDI basics
• FDA device labeling
• FDA overview of device regulation

FDA page topics were checked on October 7, 2026. Linked regulations and database records still need product-specific applicability review; public links do not establish that a device is authorized.

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