Issuing Agency [1]
Organization accredited by FDA to operate a system for the issuance of UDIs.
Recorded entry notes and format
Choose a value from the drop down List of Values (LOV).
Data type: NA
Entry values: GS1; HIBCC; ICCBBA
Compliance research
GUDID primary DI and unit-of-use DI: prepare the identifier relationship
Start with the issuing agency, the lowest-package-level primary DI and device count. The acquired FDA field table makes the unit-of-use DI conditional on device count greater than one. That relationship is different from identifying a higher packaging level; prepare both the label and the quantity relationship before mapping a portfolio.
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.
| Field | Recorded entry condition | Post-grace-period edit rule | Recorded new-DI trigger |
|---|---|---|---|
| Issuing Agency [1] | Required | None | Yes |
| Primary DI Number [2] | Required | None | Yes |
| Device Count [3] | Required | None | Yes |
| Unit of Use DI Number [4] | Conditionally Required* *If Device Count >1 | Edit | No |
Definitions and entry notes
Primary DI Number [2]
The Primary Device Identifier (DI) is the DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements. If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent. The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use.
Recorded entry notes and format
Enter the Device Identifier (DI) Number. If using GS1 as an issuing agency, ensure the check digit is correct and valid as per the GS1 guidelines. If using HIBCC or ICCBBA as an issuing agency, do not include the check digit/character as part of your DI. Data type and field length are determined by the individual Issuing Agency structure. IF Device IS Packaged Primary DI = DI portion of the UDI on the lowest package level OR IF Device is NOT Packaged Primary DI = DI on the device itself, could be DM DI GS1: Numeric (Num.), DI may be 12, 13 or 14 digit numeric value. System will append zeros to the left or beginning of DI to save a 14 digit value, include the check digit as part of the DI HIBCC: Alphanumeric (Alphanum.), with 6-23 characters, DO NOT include the check digit as part of the DI ICCBBA: Alphanum., with 10 or 16 characters
Data type: Type: Num. or Alphanum. Length: min-6, max-23* *defined by Issuing Agency structure
Entry values: NA
Device Count [3]
Number of medical devices in the base package.
Recorded entry notes and format
Enter the number of devices. Example: Base Package = Box of 100 gloves; Primary DI = 101; Device Count = 100.
Data type: Type: Num. Length: 7
Entry values: NA
Unit of Use DI Number [4]
An unmarked identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient. The Unit of Use DI does not appear on the label of the device.
Recorded entry notes and format
Enter the Unit of Use DI Number. Must be from same Issuing Agency as Primary DI. Unit of Use DI is an identifier used by hospital staff and Materials Management to account for a single device when the UDI is labeled on a higher level of packaging. The Unit of Use DI does not appear on the label. If Device Count = 1, cannot add Unit of Use DI Number. Data type and field length are determined by the individual Issuing Agency structure. GS1: Num., DI may be 12, 13 or 14 digit numeric value. System will append zeros to the left or beginning of DI to save a 14 digit value, include the check digit as part of the DI HIBCC: Alphanum., with 6-23 characters, DO NOT include the check digit as part of the DI ICCBBA: Alphanum., with 10 or 16 characters
Data type: Type: Num. or Alphanum. Length: min-6, max-23* *defined by Issuing Agency structure
Entry values: NA
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 [5]
See 21 CFR 830.310 and 830.340 for required data elements. [6]
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. [7]
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.
Confirm the agency and controlled DI
Use the actual issuing-agency record and labelled primary DI; apply the agency-specific identifier rules recorded in the table, rather than stripping leading zeroes.
Useful evidence: Issuing-agency allocation and current label artwork.
Resolve what the device count counts
Document the units represented at the primary-DI package level and whether a unit-of-use identifier is needed under the recorded condition.
Useful evidence: Package/unit drawing with count and proposed DI relationships.
Keep identifier levels separate
Give the mapper distinct primary, unit-of-use and higher-package fields; confirm the source of every identifier.
Useful evidence: A labelled identifier map and an exception list.
Work packages and dependencies
- Conditional: GUDID primary DI and unit-of-use DI: prepare the identifier relationship — 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 preserve agency-specific formats and leading zeroes?
- How will your mapping distinguish primary DI, unit-of-use DI and package DI?
- Which label/count evidence will you require before accepting the 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.
US Food and Drug Administration — published reference ↗
Mon, 16 Dec 2024 01:15:52 GMT · retrieved 2026-10-06
- [1] GUDID_Data_Elements — row 6
- [2] GUDID_Data_Elements — row 7
- [3] GUDID_Data_Elements — row 8
- [4] GUDID_Data_Elements — row 9
- [5] GUDID_Data_Elements — row 98
- [6] GUDID_Data_Elements — row 99
- [7] GUDID_Data_Elements — row 101
Audit details: precise locators and snapshot identifiers
Source key D02 · snapshot f8318545152bce0733ec399fdae290591dc81d521958ea88d7f914e426703f57
- [1] GUDID_Data_Elements!row 6 · record ad969c000e12f542bc41b102dfb091765f142c28828a7c3346820be65cdcaa4a
- [2] GUDID_Data_Elements!row 7 · record 5fe96829dd24e691fd991b51d9403f4c24d04dc8a4099445702e5a24ac7b645b
- [3] GUDID_Data_Elements!row 8 · record c5b44502110725012a6b1fcf4c94f64c5b5daf677f7d4a1b7507baf0c9a786bf
- [4] GUDID_Data_Elements!row 9 · record ae083fe02060ad6946c9200a00b157d22aa6262b8a7ceaa20b43ce227c023f3d
- [5] GUDID_Data_Elements!row 98 · record 535001122b7936cad6d5c2e127d4f824c82da28cd52e80db25cabfe07c9de67c
- [6] GUDID_Data_Elements!row 99 · record ffccb1b71368c7cd52da1fb372a1ca9e4329de68d369deee8f108ab2bdca3dd6
- [7] GUDID_Data_Elements!row 101 · record 4cfaec69a71b8c793db9c3e66d357cbb4cefa43e640103366246094fb02f16a0
Prepare an editable project brief
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.