Identity
- Trade Name
- Avoximeter Whole Blood CO-Oximeter FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, reagent FDA UDI
- Device Name
- Avoximeter 4000 Cuvettes 100 cuvettes/box FDA UDI
- Model / Reference
- QV8 FDA UDI
- Description
- Avoximeter 4000 Cuvettes 100 cuvettes/box FDA UDI
Identifiers
- Catalog Number
- QV8 FDA UDI
- Primary DI / UDI-DI
- 10711234160053 FDA UDI
- 510(k) Number
- K951485 FDA UDI
- FDA Product Code
- JKS FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas analyte IVD, reagent
Avoximeter Whole Blood CO-Oximeter by Accriva Diagnostics Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood gas analyte IVD, reagent.
- cobas b 221 GLU/LAC Cassette — Roche Diagnostics Corp. · Class I
- cobas b 221 S3 Fluid Pack — Roche Diagnostics Corp. · Class I
- Drew Scientific — Drew Scientific , Ltd. · Class I
- cobas b 221 S2 Fluid Pack — Roche Diagnostics Corp. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class I
- cobas b 221 GLU Cassette — Roche Diagnostics Corp. · Class II
- cobas b 221 GLU/LAC/UREA (BUN) Cassette — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K951485 also covers:
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- GEM OPL CUVETTES — INSTRUMENTATION LABORATORY COMPANY
- OPTICAL QC FILTERS — INSTRUMENTATION LABORATORY COMPANY
- TEMPERATURE PROBE — INSTRUMENTATION LABORATORY COMPANY
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accriva Diagnostics Holdings, Inc.
Sources (1)
- FDA UDI c274939d-a657-48f2-9f64-684a62872477 36 fields · synced May 31, 2026