Cruxi
Compliance research
The acquired full AccessGUDID release records 8,970 published device records linked to FDA product code ITX. 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.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Recorded UDI portfolio · exact code ITX
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 | 938 | 0 | 8,032 | 0 |
| Sterilization required before use | 1,410 | 0 | 7,560 | 0 |
| Single-use indicator | 1,507 | 0 | 7,463 | 0 |
| Lot/batch indicator | 2,503 | 0 | 6,467 | 0 |
| Serial-number indicator | 6,445 | 0 | 2,525 | 0 |
| Manufacturing-date indicator | 5,442 | 0 | 3,528 | 0 |
| Expiration-date indicator | 1,817 | 0 | 7,153 | 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.
| Packaged as sterile | Sterilization before use | Recorded devices |
|---|---|---|
| missing | missing | 7,009 |
| missing | true | 1,023 |
| true | missing | 551 |
| true | true | 387 |
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.
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
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.
433 of 8970 records have a parsed device count above one. Compare your controlled count to the separate primary/unit-of-use fields; the cohort cannot decide your count.
Useful evidence: Your label, package drawing, device count and proposed unit-of-use relationship.
The two columns are independent. Use the cross-table to identify the recorded variation, then map your own supplied-state and approved user-instruction evidence separately. A true flag is not a validation report.
Useful evidence: Approved packaging/labels, IFU and a separate validation-evidence question if statements are unresolved.
Compare the recorded lot/batch, serial and date indicators below with your barcode design. These are flags, not actual lot/serial/date values; missing source flags remain unknown.
Useful evidence: Approved barcode/identifier specification with the DI-level flags separated from unit and batch data.
Document your field/relationship decisions and differences from these public examples; a published record does not certify that its choices fit your product. Ask the specialist to reconcile the controlled evidence and current instructions.
Useful evidence: A field mapping, conditional-input list and controlled source-to-target reconciliation.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
Thu, 01 Oct 2026 22:24:15 GMT · retrieved 2026-10-06
Source key D03 · snapshot b9e4fee0ed7afdf9c255a6f0d353df3d17abf768423abba82bb80ceb9b79366c
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.