GUDID package hierarchy: contains-DI, quantity and discontinuation checks
A package DI is not a copy of the primary DI with a different quantity. FDA’s acquired reference describes higher packaging levels, quantity per package and the contained DI; entering a package DI makes quantity and contains-DI fields conditional requirements. Package discontinuation also has its own relationship to distribution-end data.
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.
A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers).
Recorded entry notes and format
Enter Package DI Number. Must be from same Issuing Agency as Primary DI. 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 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
Examples:
Box of Gloves = DI 101
4 Boxes of Gloves (DI 101) in a Carton = Package DI 201 (the UDI on the Carton)
5 Cartons (Pkg DI 201) in a Case = Package DI 301 (the UDI on the Case)
10 Boxes of Gloves (DI 101) in a Carton = Package DI 202 (the UDI on the Carton).
Data type: Type:
Num. or Alphanum.
Length: min-6, max-23*
*defined by Issuing Agency structure
The number of packages with the same Primary DI or Package DI within a given packaging configuration.
Recorded entry notes and format
Enter the number of devices per package.
The quantity of a package configuration must be = >1.
Examples:
Package – Carton, Pkg DI 201 contains 4 boxes of DI 101; the quantity per package is 4.
Package – Case, Pkg DI 301 contains 5 cartons of Pkg DI 201; the quantity per package is 5.
Package – Carton, Pkg DI 202 contains 10 boxes of DI 101; the quantity per package is 10.
The Primary DI for the base package or the Package DI for any lower level package configuration contained within a given package configuration.
Recorded entry notes and format
Choose a value from the drop down LOV.
Examples:
Package DI 201 (Carton) contains base package DI 101.
Package DI 202 (Carton) contains base package DI 101.
Package DI 301 contains lower level Package DI 201 (Carton).
Data type: NA
Entry values: DI numbers; base package and all lower levels of packaging
Indicates the date this particular package configuration is discontinued by the labeler.
Recorded entry notes and format
Choose date from calendar or manually enter in format yyyy-mm-dd.
Discontinuation of a package is directly related to the discontinuation of the primary DI of the base package. However, a package can also be discontinued without the discontinuation of the base package.
Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b).
Recorded entry notes and format
Auto populated based on Package Discontinue Date. If Package DI and related elements are entered and no Package Distribution End Date is entered, the status is 'In Commercial Distribution.'
Data type: NA
Entry values: In Commercial Distribution; Not in Commercial Distribution
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 [7]
See 21 CFR 830.310 and 830.340 for required data elements. [8]
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. [9]
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.
Draw the actual package tree
Identify each higher package, the DI it contains and the quantity at that relationship; check the source table before deciding the quantity basis.
Useful evidence: Packaging specification, labelled package DIs and contained-DI relationships.
Reconcile the complete chain
Check every parent/contained DI and any missing level with the responsible labeler; do not create a separate registration page for each package variant.
Useful evidence: One portfolio hierarchy worksheet with unresolved links.
Plan package changes separately
Map the package discontinue date and status alongside device commercial-distribution data; avoid silently removing historic package relationships.
Useful evidence: Distribution-end and package-discontinuation change log.
Work packages and dependencies
Conditional: GUDID package hierarchy: contains-DI, quantity and discontinuation checks — 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 do you validate contained-DI references and quantity at each level?
How are package-only changes separated from device-record changes?
How will you reconcile the hierarchy against the current labels?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
