GUDID production identifiers: flags are different from lot and serial values
The acquired FDA reference labels these production-identifier fields as indicators/flags rather than the actual identifier values. Prepare whether the label uses lot/batch, manufacturing date, serial, expiration or donation identifiers. Donation identifiers have stated HCT/P and issuing-agency conditions; do not paste individual batch or patient information into a public DI master record.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Observed FDA field relationships
Which fields change this workflow?
FDA Data Elements Reference Table; acquired link labelled December 17, 2024. Entry conditions and edit rules below are transcribed from that version.
The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.
This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined.
Recorded entry notes and format
Choose Yes/No from the drop down list.
For stand-alone software, select Yes to indicate that the software version number will be represented as a Lot or Batch number
The date on which a device is manufactured.
This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined.
The number that allows for the identification of a device, indicating its position within a series.
This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined.
The date by which the label of a device states the device must or should be used.
This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined.
The Donation Identification Number (DIN) is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation.
This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined.
Recorded entry notes and format
Choose Yes/No from the drop down list.
This PI is only applicable to HCT/P products regulated as medical devices.
IF Issuing Agency = ICCBBA,
DIC = DIN
Else IF Issuing Agency = GS1 or HIBCC then DIC = Serial Number
OR
DIC = Lot Number
OR
DIC = Serial + Lot Number
Data type: Type: Boolean
Entry values: Yes/No
Reference limits and edit-rule footnotes
Add = Addition of new data is allowed; Delete = Deletion of entered data is allowed; Edit = Editing of entered data is allowed; None = NO edit, add, or delete are allowed; NA = data element is not able to be changed directly; most are ‘auto-populated’ fields whose information depends on another data element
Note: The above do not apply if the device is “unlocked” for editing. For more information on “unlocking” device records for editing, please visit www.fda.gov/udi [6]
See 21 CFR 830.310 and 830.340 for required data elements. [7]
Most of the information presented here is applicable to GUDID HL7 SPL submissions, but there are some differences pertinent to each submission option. Please refer to the HL7 SPL Implementation package of files for additional details on HL7 SPL xml file submission option. [8]
These are dated FDA reference-table fields, not an automated legal applicability assessment or validated submission. The AccessGUDID download schema is different from the FDA HL7 SPL submission implementation package. No quarantined schema is used.
A mapping worksheet for this workflow
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Read the controlled label structure
Identify which production-identifier types are represented on the label for this DI, distinct from actual values assigned to a batch or unit.
Useful evidence: Approved label/barcode design and identifier specification.
Map flags and special conditions
Record each indicator separately, including documented HCT/P and agency facts for donation-identification conditions.
Useful evidence: DI-level indicator matrix and unresolved agency/role questions.
Check privacy and downstream separation
Keep transaction-level lots/serials and any personal data in the proper controlled system; verify only the supported DI-level flags here.
Useful evidence: Data-flow map and validation examples with sensitive values removed.
Work packages and dependencies
Conditional: GUDID production identifiers: flags are different from lot and serial values — Review the controlled source evidence, prepare the field/relationship mapping described here, resolve exceptions and reconcile the intended records before confirming submission scope.
Questions for providers
How will you distinguish indicator flags from individual lot or serial values?
How are donation-identification and issuing-agency conditions checked?
What prevents transaction-level or personal information from entering the DI master mapping?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
