The acquired full AccessGUDID release records 379 published device records linked to FDA product code FIE. Compare their recorded field relationships below when planning a portfolio mapping. The counts describe this dated public corpus, not unique product models, market size, demand, approval or a test requirement for your device. The source also contains 62 primary-DI owners with resolved package chains of two or more levels. The worked examples below separate each recorded package quantity from the base-package device count and retain atypical endpoints for reconciliation.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Recorded UDI portfolio · exact code FIE
What does this dated public cohort contain?
379Published device records
0Parsed device count above one
0Device count missing or unresolved
These are primary-DI record counts, not unique model counts or market size. A DI can be linked to more than one product code, so code cohorts must not be added as unique devices.
| Recorded indicator | True | False | Blank/missing | Unrecognized |
|---|
| Packaged as sterile | 379 | 0 | 0 | 0 |
|---|
| Sterilization required before use | 1 | 0 | 378 | 0 |
|---|
| Single-use indicator | 379 | 0 | 0 | 0 |
|---|
| Lot/batch indicator | 379 | 0 | 0 | 0 |
|---|
| Serial-number indicator | 64 | 0 | 315 | 0 |
|---|
| Manufacturing-date indicator | 82 | 0 | 297 | 0 |
|---|
| Expiration-date indicator | 379 | 0 | 0 | 0 |
|---|
A blank flag is unknown. A true indicator is a recorded label-data fact; it is not a validation report, FDA approval or a test obligation for your product.
Compare the two sterility questions independently
| Packaged as sterile | Sterilization before use | Recorded devices |
|---|
| true | missing | 378 |
| true | true | 1 |
These distinct questions describe the supplied device and user instructions. Review the exact FDA field relationship; do not infer a manufacturer’s validated process from these flags.
Source, filters, reconciliation and limitations
Join acquired full-release device.txt to distinct productCodes.txt relationships by exact PrimaryDI; filter exact FDA code and Published device-record state. Count each DI once within that code. Interpret only literal true/false; blank and unrecognized values remain separate. Parse a positive integer deviceCount for the greater-than-one indicator. Do not apply saved daily updates.
Excluded/unresolved recorded states: {}. Global source-relationship exclusions: {}.
Recorded identities/flags only. Not unique product models, market size, demand, approval, validated sterility, a compliance rate or a mandatory test plan. One DI can occur in several different code cohorts; overall cohort counts must not be added as unique devices.
Calculation gudid-exact-code-portfolio-1 · snapshot b9e4fee0ed7afdf9c255a6f0d353df3d17abf768423abba82bb80ceb9b79366c. Counts use the full release; downloaded daily updates are not applied. Corpus download: source 2 source 3 source 4 source 5 source 6 source 7 source 8 source 9 source 10 source 11 source 12 source 13 source 14
Prepare the related field workflows
Follow recorded package and unit-of-use relationships
These worked examples come from this exact product-code cohort. Use their mapping steps to check your own controlled labels and drawings. Keep the public source facts separate from your portfolio.
GUDID records production-identifier flags, rather than actual lot, serial or date values. [15]
The guidance describes a separate unit-of-use relationship for an individual device when the base package contains more than one device and the individual unit does not carry its own UDI label. [16]
Device Count counts devices in the base package. Contains DI Package identifies the lower package level; Quantity per Package counts packages inside that particular configuration. Keep these fields separate. [17]
| Resolved package levels to the Primary DI | Recorded primary-DI owners |
|---|
| 0 (0 means no resolved package-to-primary path) | 139 |
| 1 (0 means no resolved package-to-primary path) | 178 |
| 2 (0 means no resolved package-to-primary path) | 62 |
Reference Primary DI 08888483005055
Recorded base device count: 1. Public version 2 dated 2018-03-29. Recorded device distribution: In Commercial Distribution. [3]
| Recorded identifier role | DI and agency | Contains DI | Package quantity | Recorded package status / end date |
|---|
| Package | 58888483005050 · GS1 [4] | 38888483005056 | 10 | In Commercial Distribution / Not recorded |
| Primary | 08888483005055 · GS1 [5] | Not recorded | Not recorded | Not recorded / Not recorded |
| Package | 38888483005056 · GS1 [6] | 08888483005055 | 50 | In Commercial Distribution / Not recorded |
Recorded path: 58888483005050 → 38888483005056 (quantity 10) → 08888483005055 (quantity 50) · endpoint: Primary.
Recorded path: 38888483005056 → 08888483005055 (quantity 50) · endpoint: Primary.
PI flags: lot/batch true, serial true, manufacturing date true, expiration date true. These are indicators; no actual unit or batch values are shown.
Reference Primary DI 06948082700590
Recorded base device count: 1. Public version 2 dated 2021-06-14. Recorded device distribution: In Commercial Distribution. [7]
| Recorded identifier role | DI and agency | Contains DI | Package quantity | Recorded package status / end date |
|---|
| Primary | 06948082700590 · GS1 [8] | Not recorded | Not recorded | Not recorded / Not recorded |
| Package | 16948082700597 · GS1 [9] | 06948082700590 | 50 | In Commercial Distribution / Not recorded |
| Package | 26948082700594 · GS1 [10] | 16948082700597 | 10 | In Commercial Distribution / Not recorded |
Recorded path: 16948082700597 → 06948082700590 (quantity 50) · endpoint: Primary.
Recorded path: 26948082700594 → 16948082700597 (quantity 10) → 06948082700590 (quantity 50) · endpoint: Primary.
PI flags: lot/batch true, serial Not recorded, manufacturing date true, expiration date true. These are indicators; no actual unit or batch values are shown.
Reference Primary DI 00383790000284
Recorded base device count: 1. Public version 3 dated 2018-12-20. Recorded device distribution: In Commercial Distribution. [11]
| Recorded identifier role | DI and agency | Contains DI | Package quantity | Recorded package status / end date |
|---|
| Primary | 00383790000284 · GS1 [12] | Not recorded | Not recorded | Not recorded / Not recorded |
| Package | 40383790000282 · GS1 [13] | 10383790000281 | 10 | In Commercial Distribution / Not recorded |
| Package | 10383790000281 · GS1 [14] | 00383790000284 | 50 | In Commercial Distribution / Not recorded |
Recorded path: 40383790000282 → 10383790000281 (quantity 10) → 00383790000284 (quantity 50) · endpoint: Primary.
Recorded path: 10383790000281 → 00383790000284 (quantity 50) · endpoint: Primary.
PI flags: lot/batch true, serial Not recorded, manufacturing date Not recorded, expiration date true. These are indicators; no actual unit or batch values are shown.
Selection, computation and source limits
Use the existing checksum-matched full release and exact-code device/product-code cache. Project literal identifier rows under their recorded PrimaryDI owner. Follow Package containsDINumber only within that owner and at most sixteen links. Preserve missing, ambiguous, cyclic and non-Primary endpoints; do not infer or repair them. Count one primary-DI owner per code. Package quantity counts packages at the next recorded level; it is not inferred from deviceCount and no total-unit calculation is performed. PI pairs count literal field states, not individual lot/serial/date values. At most three distinct mapping patterns with no more than twelve literal identifier rows per owner. Prefer atypical package endpoints, then deeper resolved package chains, then multi-device base packages with unit-of-use identifiers, then descending PrimaryDI. Full cohort counts include all published exact-code owners.
Package endpoints: {'Primary': 302}. Quantity states: {'positive-integer': 302}.
These are literal relationships in a dated public full release. Daily updates are not applied. A package or device distribution field is a recorded status, not current stock or provider availability. Unknown, ambiguous or atypical relationships need reconciliation; none establishes a breach. The examples are not prescribed label designs, validated quantities, approval, regulatory equivalence or facts about the buyer.
Calculation gudid-literal-relationship-research-1 · snapshot b9e4fee0ed7afdf9c255a6f0d353df3d17abf768423abba82bb80ceb9b79366c.
