Compliance research

GUDID premarket references, product codes and listing numbers: map separate identifiers

Do not merge a premarket submission reference, FDA product code and device listing number into a single “FDA ID”. The acquired reference has separate fields, conditional exemption/submission alternatives, supplement information and stated exceptions to product-code/listing data. Establish the device and submission context before applying those conditions; a GUDID entry is not FDA approval. A worked NFV/NGG reconciliation below turns 4,179 recorded code links into 2,193 distinct source owners and 2,709 typed identifier rows. Keeping separate owner, code-link and identifier tables prevents duplicate master records and lost package or PI information; these source codes are not an assignment for your device.

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
Device Exempt from Premarket Submission [1]	Conditionally Required* *Premarket Submission Number OR exempt status fulfills regulatory requirement	None	No
FDA Premarket Submission Number [2]	Conditionally Required* *Premarket Submission Number OR exempt status fulfills regulatory requirement	Add	No
Supplement Number [3]	Conditionally Required* *Premarket Submission Number OR exempt status fulfills regulatory requirement	Add	No
Product Code [4]	Conditionally Required* *Unless device is a kit or IVD with a BL premarket submission number	Add Delete Edit	No
Product Code Name [5]	Auto Populated	NA	No
FDA Listing Number [6]	Conditionally Required* *Unless device is an HCT/P with a BL premarket submission number	Add	No

Definitions and entry notes

Device Exempt from Premarket Submission [1]

FDA Premarket submission is not required for this device.

Recorded entry notes and format

Select checkbox if 1) FDA has by regulation exempted this device from premarket submission requirements; 2) This is a pre-amendment device; or 3) FDA has by final guidance published its intent not to enforce the premarket submission requirements for this device.

Data type: Type: Boolean

Entry values: NA

FDA Premarket Submission Number [2]

The FDA premarket submission number of those products requiring premarket approval or notification before being marketed in the U.S., including medical devices and products with medical device constituents regulated by CDER, CBER and CDRH. Petition number for devices granted marketing authorization via a De Novo petition is also accepted in the FDA Premarket Submission Number field. Submission types included are 510(k), De Novo, PMA, PDP, HDE, BLA, ANDA, NDA and BR.

Recorded entry notes and format

Enter current FDA Premarket Submission Number(s). Each DI record represents a version or model of a device. For each DI record, you must submit the premarket authorization number and, if applicable, the supplement number through which you originally obtained approval or clearance or were granted classification for the version or model identified in the DI record, as required by 830.310(b)(11). FDA Premarket Numbers should be verified with the corresponding FDA premarket database to make sure the Number is consistent with the device record. Device records should be updated with additional numbers in the future, as needed. FDA Premarket Supplement number is collected as a separate field (if the model or version was approved in a PMA, HDE, BLA, or NDA supplement). Example: De Novo #123456 should be entered as 'DEN123456.' Example: PMA # P190010/S46 should be entered as 'P190010' in the 'FDA Premarket Submission Number' field

Data type: Type: Alphanum. Length: 10

Entry values: NA

Supplement Number [3]

The supplemental application number for product changes requiring approval, including medical devices and products with medical device constituents regulated by CDER, CBER and CDRH. Submission types included are PMA, PDP, HDE, BLA, ANDA, NDA and BR.

Recorded entry notes and format

Enter all valid Supplement Numbers. Each DI record represents a version or model of a device. For each DI record, you must submit the premarket authorization number (if the model or version was originally approved in a PMA, HDE, BLA, or NDA supplement) and the supplement number through which you originally obtained approval for the version or model identified in that DI record, as required by 830.310(b)(11). Although not all supplements are applicable to a given model or version, if FDA approves a subsequent supplement applicable to that version or model, the GUDID DI record must be updated with that supplement number, in accordance with 21 CFR 830.330(b). 30 day notice supplements should be submitted ONLY if the 30 day notice impacts the device design specifications, or performance of the finished devices. Do not enter alpha characters. Example: Supplement 4 should be entered as '4'.

Data type: Type: Num. Length: CDRH - min-1, max-3 CBER - min-1, max-4 CDER - min-1, max-4

Entry values: NA

Product Code [4]

Categorization for devices used by the FDA.

Recorded entry notes and format

Enter all applicable Product Codes, three-letter code. For all PMA, 510k, HDE and De Novo devices, product codes are assigned in the FDA approval, clearance or classification letter, respectively. If the product code is down classified then use the same product code that was used to register and list the device. For most De Novo devices, the product code can be found in the reclassification order.

Data type: Type: Alpha Length: 3

Entry values: FDA Product Code list

Product Code Name [5]

Name associated with the three-letter Product Code.

Recorded entry notes and format

Auto populated based on 3-letter Product Code

Data type: NA

Entry values: NA

FDA Listing Number [6]

Number assigned by FDA during Registration and Listing to all devices in commercial distribution, regardless of pre-market authorization requirements per 21 CFR 807.28(f).

Recorded entry notes and format

Enter all relevant listing numbers that enable the labeler to commercially distribute the given version or model of device. Listing number is optional for HCT/P devices with a BLA premarket number.

Data type: Type: Alphanum. Length: 7

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 [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.

Worked database reconciliation

Two code exports, one owner table

The acquired NFV and NGG relationships overlap. Keep device owners, recorded product-code links and typed identifiers in separate tables so a many-to-many join does not duplicate master data.

Mapping result	Source count	What changes in the work
Exact NFV owner/code links	2,017	Retain this code relationship with its own source/version.
Exact NGG owner/code links	2,162	Retain this code relationship separately; overlap does not make the codes equivalent.
Owners shared by the two codes	1,986	A source owner belongs once in the device table, with both code links.
NFV-only / NGG-only in this pair	31 / 176	Keep these owners; pair exclusivity does not exclude other recorded codes.
Deduplicated source owners	2,193	Use one owner row within this immutable snapshot.
Retained code-link rows	4,179	Keep all pair relationships in a separate code-link table.
Typed identifier rows under the owner union	2,709	Retain role, issuing agency, contained DI and subordinate fields.
Repeated owner / identifier copies if stacked	1,986 / 2,386	Remove duplicate copies created by the two export joins, without merging different source owners.

Counts concern public source records and relationships in one dated release. They are not model counts, market size or an assignment of NFV/NGG to your device.

Field meanings and source limits

GUDID records production-identifier flags rather than actual lot, serial or date values. [82]

The guidance describes a separate Unit of Use relationship; keep identifier roles distinct. [83]

Device Count concerns devices in the base package. Contains DI and Quantity per Package describe the recorded lower package level; keep these quantities separate. [84]

The FDA reference describes the Public Device Record Key as identifying a device record even if the Primary DI changes. [85]

Six examples to test the mapping

Six explicitly selected source owners exercise nested packages, independent subordinate statuses, Previous DI, repeated structure, alphanumeric identity and unknown PI flags. They are not representative or buyer-assigned devices.

Reference owner 00860004081609 [10]

Keep one owner and both code links; trace each recorded level of its nested packages.

Recorded pair links: NFV, NGG [11] [12]. Base device count: 1.

Owner-level field	Literal source value
publicDeviceRecordKey	3ad277b5-1210-4531-8f4c-bd6f5162fedf
publicVersionStatus	Update
publicVersionNumber	3
publicVersionDate	2022-06-10
deviceCommDistributionStatus	Not in Commercial Distribution
deviceCommDistributionEndDate	2021-12-31
lotBatch	true
serialNumber	Blank in source (unknown)
manufacturingDate	true
expirationDate	true

The lot, serial and date fields are indicators; individual production-identifier values are not supplied here. Keep a blank unknown and preserve each package status independently.

Identifier / source	Recorded role	Agency	Contains DI	Package quantity	Package status	Package end date
00860004081616 [23]	Package	GS1	00860004081609	3	Not in Commercial Distribution	2021-12-31
00860004081623 [24]	Package	GS1	00860004081609	25	Not in Commercial Distribution	2021-12-31
00860004081630 [25]	Package	GS1	00860004081623	4	Not in Commercial Distribution	2021-12-31
00860004081609 [26]	Primary	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)

Other source code links — outside this pair comparison

NGM [13] QAW [14] PTH [15] NFT [16] NGI [17] NFW [18] PTG [19] QBF [20] NGL [21] NFY [22]

These recorded links do not assign codes to your product or establish equivalence.

Reference owner 00722066004548 [27]

Keep the Unit of Use relationship and each package status separately from the device-level status.

Recorded pair links: NFV, NGG [28] [29]. Base device count: 25.

Owner-level field	Literal source value
publicDeviceRecordKey	c3a99d6f-cd61-4b52-8c5a-4edd6b21fa58
publicVersionStatus	Update
publicVersionNumber	6
publicVersionDate	2025-11-18
deviceCommDistributionStatus	In Commercial Distribution
deviceCommDistributionEndDate	Blank in source (unknown)
lotBatch	true
serialNumber	Blank in source (unknown)
manufacturingDate	Blank in source (unknown)
expirationDate	true

The lot, serial and date fields are indicators; individual production-identifier values are not supplied here. Keep a blank unknown and preserve each package status independently.

Identifier / source	Recorded role	Agency	Contains DI	Package quantity	Package status	Package end date
00722066004548 [39]	Primary	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)
17220660045481 [40]	Package	GS1	00722066004548	6	Not in Commercial Distribution	2025-10-03
10722066004545 [41]	Package	GS1	00722066004548	25	In Commercial Distribution	Blank in source (unknown)
00722066004555 [42]	Unit of Use	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)

Other source code links — outside this pair comparison

QAW [30] NFW [31] NFT [32] PTH [33] NFY [34] PTG [35] NGL [36] QBF [37] NGM [38]

These recorded links do not assign codes to your product or establish equivalence.

Reference owner 00817405021239 [43]

Retain Previous and Primary as different identifier roles; do not overwrite the current owner with its Previous DI.

Recorded pair links: NFV [44]. Base device count: 1.

Owner-level field	Literal source value
publicDeviceRecordKey	157828cc-3494-4491-9536-b20bc0d19fec
publicVersionStatus	Update
publicVersionNumber	7
publicVersionDate	2024-10-14
deviceCommDistributionStatus	In Commercial Distribution
deviceCommDistributionEndDate	Blank in source (unknown)
lotBatch	true
serialNumber	Blank in source (unknown)
manufacturingDate	Blank in source (unknown)
expirationDate	true

The lot, serial and date fields are indicators; individual production-identifier values are not supplied here. Keep a blank unknown and preserve each package status independently.

Identifier / source	Recorded role	Agency	Contains DI	Package quantity	Package status	Package end date
00817405021239 [49]	Primary	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)
00858998006050 [50]	Previous	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)

Other source code links — outside this pair comparison

NGL [45] NFT [46] NFW [47] NFY [48]

These recorded links do not assign codes to your product or establish equivalence.

Reference owner 00850076289706 [51]

Retain a different owner even when its package and PI pattern resembles another example.

Recorded pair links: NFV [52]. Base device count: 25.

Owner-level field	Literal source value
publicDeviceRecordKey	bce8e7f0-b7cf-4b4a-9f69-680c65764f36
publicVersionStatus	New
publicVersionNumber	1
publicVersionDate	2026-07-28
deviceCommDistributionStatus	In Commercial Distribution
deviceCommDistributionEndDate	Blank in source (unknown)
lotBatch	true
serialNumber	Blank in source (unknown)
manufacturingDate	Blank in source (unknown)
expirationDate	true

The lot, serial and date fields are indicators; individual production-identifier values are not supplied here. Keep a blank unknown and preserve each package status independently.

Identifier / source	Recorded role	Agency	Contains DI	Package quantity	Package status	Package end date
10850076289703 [60]	Package	GS1	00850076289706	4	In Commercial Distribution	Blank in source (unknown)
00850076289706 [61]	Primary	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)
20850076289700 [62]	Unit of Use	GS1	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)

Other source code links — outside this pair comparison

NFT [53] NGM [54] NGL [55] NFW [56] PTG [57] PTH [58] NFY [59]

These recorded links do not assign codes to your product or establish equivalence.

Reference owner B2983092110 [63]

Preserve the alphanumeric HIBCC identifier and its literal serial/lot flags; blank is unknown.

Recorded pair links: NGG [64]. Base device count: 1.

Owner-level field	Literal source value
publicDeviceRecordKey	9db8a0ab-b9fe-4d00-9b14-c7ed1f5f573e
publicVersionStatus	Update
publicVersionNumber	3
publicVersionDate	2022-06-10
deviceCommDistributionStatus	In Commercial Distribution
deviceCommDistributionEndDate	Blank in source (unknown)
lotBatch	Blank in source (unknown)
serialNumber	true
manufacturingDate	Blank in source (unknown)
expirationDate	true

The lot, serial and date fields are indicators; individual production-identifier values are not supplied here. Keep a blank unknown and preserve each package status independently.

Identifier / source	Recorded role	Agency	Contains DI	Package quantity	Package status	Package end date
B2983092110 [72]	Primary	HIBCC	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)

Other source code links — outside this pair comparison

NFT [65] JXM [66] DIS [67] LDJ [68] DJR [69] NFY [70] DJG [71]

These recorded links do not assign codes to your product or establish equivalence.

Reference owner G474M2107010 [73]

Join an alphanumeric package and contained DI losslessly; keep issuing agency, role and quantity.

Recorded pair links: NGG [74]. Base device count: 1.

Owner-level field	Literal source value
publicDeviceRecordKey	e2b21460-2cad-4678-be44-e879fabea24a
publicVersionStatus	New
publicVersionNumber	1
publicVersionDate	2026-07-28
deviceCommDistributionStatus	In Commercial Distribution
deviceCommDistributionEndDate	Blank in source (unknown)
lotBatch	true
serialNumber	Blank in source (unknown)
manufacturingDate	Blank in source (unknown)
expirationDate	true

The lot, serial and date fields are indicators; individual production-identifier values are not supplied here. Keep a blank unknown and preserve each package status independently.

Identifier / source	Recorded role	Agency	Contains DI	Package quantity	Package status	Package end date
G474M2107010 [79]	Primary	HIBCC	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)	Blank in source (unknown)
G474M2107011 [80]	Package	HIBCC	G474M2107010	25	In Commercial Distribution	Blank in source (unknown)

Other source code links — outside this pair comparison

NFW [75] NGL [76] NFY [77] NFT [78]

These recorded links do not assign codes to your product or establish equivalence.

This worked reconciliation uses one dated public full release; daily updates are not applied. NFV-only and NGG-only mean only relative to this pair, not to every recorded product code. Neither overlap nor an identifier pattern establishes code equivalence, clinical route, buyer assignment, approval, validated packaging, current stock or market size. These examples are reference data, not facts about your product.

Use the worksheet below to prepare your own controlled owner, code-link and typed-identifier tables.

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.

Collect distinct official references
Obtain submission number, relevant supplement, product-code evidence and device-listing information separately.
Useful evidence: Official record links and the labeler’s regulatory master data.
Review conditional exceptions
Record whether the device is exempt, a kit, an IVD or an HCT/P and the relevant submission context; ask the specialist to apply the exact recorded condition.
Useful evidence: Documented device/context assessment and unresolved exception checks.
Check the portfolio mapping
Reconcile each supplied identifier to the intended DI and retain disagreements for review; do not infer a route or predicate from matching names.
Useful evidence: DI-to-regulatory-reference matrix with source/version for each entry.
Create one source-owner table
Keep one device row per exact owner within the snapshot. Retain publicDeviceRecordKey, PrimaryDI and public-version fields separately so a code link does not duplicate device/PI facts and a later DI change does not erase source identity.
Useful evidence: source_snapshot | PrimaryDI (text) | publicDeviceRecordKey | publicVersionNumber | publicVersionDate | deviceCount | lotBatch | serialNumber | manufacturingDate | expirationDate | source locator
Keep a separate code-link table
Retain each exact source-owner/product-code relationship with its evidence and version. The example pair has 1,986 shared owners; overlap does not make the codes interchangeable or prove your assignment. Preserve other recorded codes in your own reconciliation where relevant.
Useful evidence: source_snapshot | PrimaryDI (text) | productCode | productCodeName | source locator | buyer-assignment evidence or unresolved mismatch
Keep typed identifiers and independent package fields
Preserve Primary, Previous, Unit of Use and Package roles, issuing agency, exact contained-DI links, literal quantities and subordinate statuses. Stacking the two example cohorts would repeat 2,386 identifier-row copies. Blank PI fields remain unknown; package quantities are not inferred from deviceCount.
Useful evidence: source_snapshot | owning PrimaryDI | deviceId (text) | deviceIdType | issuing agency | containsDINumber | pkgQuantity | package status/end date | source locator

Work packages and dependencies

Conditional: GUDID premarket references, product codes and listing numbers: map separate identifiers — Review the controlled source evidence, prepare the field/relationship mapping described here, resolve exceptions and reconcile the intended records before confirming submission scope. Include lossless owner/code/typed-identifier reconciliation and the exceptions illustrated by the dated worked examples.

Questions for providers

Which evidence will you use to check submission, supplement, product-code and listing relationships?
How do you handle the stated conditional exceptions?
Which mismatches require regulatory review before upload?
Can you produce separate owner, code-link and typed-identifier tables and reconcile duplicate joins, Previous DIs, alphanumeric IDs, package statuses and unknown PI fields without assigning a code by name similarity?

Open questions and limits

Buyer labels, identifiers, portfolio facts and record state remain incomplete. This page does not establish approval, validated safety or a final applicability conclusion.
The dated field reference is technical documentation. Current legal requirements, any unlock arrangement and submission-option differences require confirmation.
Downloaded AccessGUDID full data and any saved daily updates do not themselves prove the update chain has been applied or reconciled.
This worked reconciliation uses one dated public full release; daily updates are not applied. NFV-only and NGG-only mean only relative to this pair, not to every recorded product code. Neither overlap nor an identifier pattern establishes code equivalence, clinical route, buyer assignment, approval, validated packaging, current stock or market size. These examples are reference data, not facts about your product.

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

Audit details: precise locators and snapshot identifiers

Source key D02 · snapshot f8318545152bce0733ec399fdae290591dc81d521958ea88d7f914e426703f57

[1] GUDID_Data_Elements!row 49 · record 627c97ba71240b5e24607ef4eb5cf1da1d435b8b11b6bab73b2d8626f3dbc67e
[2] GUDID_Data_Elements!row 50 · record f2b984fa3b747548029f80c8d96f069286e9453b3ea4d7b10b21cf52b46facc6
[3] GUDID_Data_Elements!row 51 · record 401254f155f27a6ee6196a9e99e5027d1cc37b03ffc2d52ecdc4158c52a10221
[4] GUDID_Data_Elements!row 53 · record 21763618df44d6f6ae671b194a193ca50ded274c42403776a5481f7a8de707ce
[5] GUDID_Data_Elements!row 54 · record dfd206828a20a9105398847af9186ad138deb23b600695238a506d49d16f81ac
[6] GUDID_Data_Elements!row 56 · record d752f246d113958cdb0592a6c62080760c6b4dc17fb67eeee7486c5137d319b2
[7] GUDID_Data_Elements!row 98 · record 535001122b7936cad6d5c2e127d4f824c82da28cd52e80db25cabfe07c9de67c
[8] GUDID_Data_Elements!row 99 · record ffccb1b71368c7cd52da1fb372a1ca9e4329de68d369deee8f108ab2bdca3dd6
[9] GUDID_Data_Elements!row 101 · record 4cfaec69a71b8c793db9c3e66d357cbb4cefa43e640103366246094fb02f16a0
[85] GUDID_Data_Elements!row 93 · record acad400145a487c4b23a1a8a30117c82299e7258d1f4ce519e24d406a9f901fa

AccessGUDID — device identifier release ↗

Thu, 01 Oct 2026 22:24:15 GMT · retrieved 2026-10-06

Audit details: precise locators and snapshot identifiers

Source key D03 · snapshot b9e4fee0ed7afdf9c255a6f0d353df3d17abf768423abba82bb80ceb9b79366c

[10] device.txt:row 1331889 · record 4a92b3bfcd95430297939b5e4712f3f027b416ac8eabe02d82ad0b960612aef8
[11] productCodes.txt:row 1872348 · record aa47d69b8fda80beba04fae8731f49e869432e5d4abbbff8f53bed5bd3433db3
[12] productCodes.txt:row 1872354 · record fa5e6558cbc10225762d635bae81caeb3242eead413f2208550dde2190515f28
[13] productCodes.txt:row 1872349 · record 2544735a228937b854a8ae8d9fe9e62aeeee3b6302e6bcffbab1d6c14e52b429
[14] productCodes.txt:row 1872351 · record 61619cfcf2b3d77ff7c9c254fa3b601ea3f7ee649f92816eaa68c11554fe6cf2
[15] productCodes.txt:row 1872350 · record 776c40a31b74b6dd7dac5ac11f07bae4b9f213b7ae904120aa540fabcbfe05bd
[16] productCodes.txt:row 1872352 · record 79ffd5f3e95bb9d53119c9c282eda57e959860940f0ffc9b980b6b4cd81119db
[17] productCodes.txt:row 1872345 · record 8c6dad4a9adbce91381638c26dd6acba7f062890565f60694752a3073d6c6f8e
[18] productCodes.txt:row 1872353 · record 931807a4821007f5751bab48d9db624db476095e2871d80fb261983174aec5c0
[19] productCodes.txt:row 1872347 · record c32662c8ea156ca5951f77a3330744c290ad46369c9961398d8a6e861b45faf9
[20] productCodes.txt:row 1872343 · record c71784f7cd960a4d95d943128a08597719f83d3ac9eb9a8912a4e7c248fe0aae
[21] productCodes.txt:row 1872346 · record d73534bdb37dc94d3005964dd20e42cb7f9840d33827931059cf239c2201f77d
[22] productCodes.txt:row 1872344 · record ec5da3804d7e4d796e2b5c78a49b972653ebdb26256f85155ff82106872e2fbd
[23] identifiers.txt:row 1578535 · record 21af60636cab47d26268857837b9129af529ad6380d53f8d1569e74a7ac149ba
[24] identifiers.txt:row 1578536 · record 2b2d9c64a3faf84407d1145be2a8acc24f8b6ac514140ea4267fae95183a7c64
[25] identifiers.txt:row 1578537 · record 4b17d33bda9b1f9c7a7466668447704ad16e51158e85d5749a274521207a49f3
[26] identifiers.txt:row 1578534 · record 96623b862e2dfd37c6341a6ab1b07ed7fbef75365b25991d8707b5848194d54b
[27] device.txt:row 2328563 · record f89f315fc03ec61eb9d8b79a7ea3f49a25a5c8b24f3ac98265fe02cb4d2ef910
[28] productCodes.txt:row 3093488 · record 08900e182eb75aed4a552533dd1b72d848b91db1df9ffcb810bd9f81ba289897
[29] productCodes.txt:row 3093491 · record c5083b06282ba39b3aa71d8a9a09934a3812fbb0200cbcf81c1ffd151005fbef
[30] productCodes.txt:row 3093483 · record 0adb37c451ccf6364505e4d8574da069931ccff765c84871b774e2bdcf8a4625
[31] productCodes.txt:row 3093490 · record 103c38b07843280901b2203106429d2353a4873953b0ddc97e3b424031ee12ea
[32] productCodes.txt:row 3093492 · record 2d02fd9abecb92b221b656cb25d9ea01e1ee9c8d32a2895261f83b99a3846428
[33] productCodes.txt:row 3093484 · record 37bacef369a1ac63cf332e5f61713a1cc24c35ebc9bc68df5539fd21ef8dd68c
[34] productCodes.txt:row 3093489 · record 3e2b085a339fb5956d8fd9ba8e69d4534a96cc98c8d8d21b9b903beed77e767e
[35] productCodes.txt:row 3093485 · record 778223954e20ef64356412d35bdf4b28770ad0303809dff7fca75218bbf23f5d
[36] productCodes.txt:row 3093487 · record 98704261ddfad67a13ce63dc162553aeec0c3cdee65ff1ac5d2c6a4da2b6bc9c
[37] productCodes.txt:row 3093482 · record a3a663fb1a8c2bbbe69514c99493fe13f7e3b6804de9ade54ddf5321c477b826
[38] productCodes.txt:row 3093486 · record cca8024f07cc63e0ced2a4e08b5043ae3902e9d8418b0607d93f3f14de77a538
[39] identifiers.txt:row 2773026 · record 1e393e614e16ad4cc3261c1f65a7517c547bdc354b0447b664eb7791d88498c6
[40] identifiers.txt:row 2773028 · record 2cde639e1bd5505597a05978f1b974785046e5bce5a177c7a3d19ee689292971
[41] identifiers.txt:row 2773029 · record 3496f6b4945d12c8add46d4e95b48741f025e3a077d7c76f827b4eaf7161c847
[42] identifiers.txt:row 2773027 · record fc73d466390bce2f03bc2d7682e3faed48d6a4e3475889501d66124406cc0425
[43] device.txt:row 2018174 · record f3c42b7a0b0f56a1c811229d1a427def4802d4cbe31ef4105f677741c2c668b2
[44] productCodes.txt:row 2752112 · record e621160e753fa3efc6d50bfaa9426df9b2f49c24713f7323898abd7fbd401b68
[45] productCodes.txt:row 2752110 · record 212c8b9842893c91dfa6add3eecb1c335cd9b39a993908814fbe0c71f1d68f45
[46] productCodes.txt:row 2752113 · record 3e75c36b7412b1b0a4180e0aaaaeff0206ddead40014153cdc224d17bf1ccfee
[47] productCodes.txt:row 2752109 · record aca1fe6608bd42242e6f4c1202b460204eb294f41e34a88decf942a09f917b4e
[48] productCodes.txt:row 2752111 · record fcebfac67c04f0f64dccaf9035d98296d1d917e42b5d46750d4f9a968ba76991
[49] identifiers.txt:row 2370512 · record 10fbbe7a9b429fe1913057cee4cd7691265730f7e5a434c21e41b2a426642ded
[50] identifiers.txt:row 2370513 · record eb29f648082175c2655a4da75598a7464c25b187501020522140b35967676804
[51] device.txt:row 1388031 · record 208c996f907303be1d5083d025156c2df1e0184207c8c591a73d4a77a02c96e8
[52] productCodes.txt:row 1934815 · record 661474b40586be5a930c960304730a031ddbddc09aed337f904b6c10de4d29a5
[53] productCodes.txt:row 1934816 · record 03f2a9efc5bd8ace1b47231991972d642418b978b0ccedb51d86575572733e7e
[54] productCodes.txt:row 1934811 · record 0fc42507b7d4d9240ab644f819c4e2a02e728a00de7692a71dc9dfd0aecd7ddc
[55] productCodes.txt:row 1934812 · record 2214067a2e9b92f717dbda281a1af882dd19ccfc95dbd851818a4fd121713426
[56] productCodes.txt:row 1934814 · record 3649b31043e2fef1ad765f2fc5145d1978ac6dcdf1c34402d67e2332d8811cf2
[57] productCodes.txt:row 1934810 · record 37247b42182a9387b05d033bd191d029cde7cb99fca8ea012a3abec229103591
[58] productCodes.txt:row 1934809 · record 52a855713eff8c3f34b4029482366524102ae95b08f4f51146125cef507742c4
[59] productCodes.txt:row 1934813 · record 635cb8c63f99c5f7f431949e18f1cf8862ddece12cf34e255f989b1b1519c9dd
[60] identifiers.txt:row 1654570 · record 46953969aea2744ebe8ee853507a8b22103fb8c64d890776ab35cd7822cca247
[61] identifiers.txt:row 1654571 · record 60bfdd264931b3f911995ac4dc305067602b8c68273f22c45b7ec9ac516d363f
[62] identifiers.txt:row 1654572 · record edeee860dcd872f2056d38ded13250c902d1e238022da7f1cd18c662cdb0fe87
[63] device.txt:row 3119670 · record fe4f48259c38adc844f620165c435cfa5872f0c90daaa5798a21b122c15014a7
[64] productCodes.txt:row 4089974 · record 51c9b5ae038aabfdddef077da3a097106532856cc790b946fb65650421b932b8
[65] productCodes.txt:row 4089978 · record 08873a434aa828918bf5d780a132aee6675254f060f0e5e64bf50e9c4f31c8ed
[66] productCodes.txt:row 4089976 · record 217239c47079022ef12b2dc78c678af1a9b44156bc74f148384b000870cc5850
[67] productCodes.txt:row 4089977 · record 2798445be9a91e17bbc0b950be1ae6299dbcdc87cfc885337ec4d5207b07da75
[68] productCodes.txt:row 4089971 · record 45645085b6b855e63d8cb7b3ecd125308f950f61859818419b1871151adfe346
[69] productCodes.txt:row 4089973 · record a460133eb891827bfe66b4a6ea441662af53001f053af55f38f7d7008cf6cb8e
[70] productCodes.txt:row 4089975 · record d5fb80f572cba5659ba195e83987dcbbb65f908c8ca8b472e15c383fabd56020
[71] productCodes.txt:row 4089972 · record ff2a8ae69deff9165e87c94de1c4bf59660d75debd4700bd89ff9d2f376504be
[72] identifiers.txt:row 3704821 · record 2281f2bb0ec5565a586645e3c47c6e3d3c05d10205612c963255cbee7035fa93
[73] device.txt:row 4942638 · record 19d9e7028ebecc7fb79710d6453927ade5a784f0e3701648ef87b2e141a432af
[74] productCodes.txt:row 6225216 · record 302583d35a80e70b3af22c25aa640ae14f852a0919f099bb4f2fe03cea41469e
[75] productCodes.txt:row 6225218 · record 271ed2c6f68df03ecd1a3e44f429a3659c72dd5314684bae2759da713d573e38
[76] productCodes.txt:row 6225217 · record 2c3ef785ae51cb1ab126395be93d63d1cffb3d5970a9bf939fa76bc7ad37d096
[77] productCodes.txt:row 6225215 · record 5b5a31c299d96fed0d1d6cce83367a343af6bb0917562ae06499f80e4a111c7e
[78] productCodes.txt:row 6225214 · record 7c7394240d0b57f30d68258ebc49ede675691f83c4e6b45eaf74897d103941db
[79] identifiers.txt:row 6494547 · record 06067b9c9171644d6c8c1f6236610a59488962c6a5812cbdbb863576be0fb05a
[80] identifiers.txt:row 6494546 · record 1a853b687393f774a1e83d5a6f3602ecfa985913f50f7be329759735b5aeefa6
[81] Complete published NFV/NGG owner union from device.txt, productCodes.txt and identifiers.txt; exact owner/code relationships · record whole dataset partition

US Food and Drug Administration — published reference ↗

Tue, 17 Dec 2024 13:41:17 GMT · retrieved 2026-10-06

Audit details: precise locators and snapshot identifiers

Source key D02 · snapshot 9b46b39b59d5267728273fa07f022e3db1d3b29b1d367fb8d67c82d6dc5f2669

[82] PDF page 13 · record 13c54a9360f8d5ea151e2ed112d02397cb33e441c918b6d0a9490987e22a1e92
[83] PDF page 14 · record 0092094d4c54b088b4c597af1077dfbaa8f570cef0f4423f6e7e1a3ca7db629d
[84] PDF page 15 · record f3f192c1339fee149ab5d7e746e1f073aeeb63f2b2efc6e648bb04403f250c83

Prepare an editable project brief

Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.

Compare FDA GUDID Submission Tools

GUDID premarket references, product codes and listing numbers: map separate identifiers

Which fields change this workflow?

Definitions and entry notes

Device Exempt from Premarket Submission [1]

FDA Premarket Submission Number [2]

Supplement Number [3]

Product Code [4]

Product Code Name [5]

FDA Listing Number [6]

Two code exports, one owner table

Field meanings and source limits

Six examples to test the mapping

Reference owner 00860004081609 [10]

Reference owner 00722066004548 [27]

Reference owner 00817405021239 [43]

Reference owner 00850076289706 [51]

Reference owner B2983092110 [63]

Reference owner G474M2107010 [73]

A mapping worksheet for this workflow

Collect distinct official references

Review conditional exceptions

Check the portfolio mapping

Create one source-owner table

Keep a separate code-link table

Keep typed identifiers and independent package fields

Work packages and dependencies

Questions for providers

Sources and data dates

US Food and Drug Administration — published reference ↗

AccessGUDID — device identifier release ↗

US Food and Drug Administration — published reference ↗

Prepare an editable project brief