Identity
- Trade Name
- Calibration Mixture FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, calibrator FDA UDI
- Device Name
- GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Calibration Mixture FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Calibration Mixture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009591844 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6400 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas analyte IVD, calibratorBlood gas analyser IVD, point-of-care
Calibration Mixture by Industrial Source — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas analyser IVD, point-of-care.
- Calibration Mixture — RED BALL OXYGEN COMPANY · Class I
- Clinical Blood Gas Mixture — A-OX WELDING SUPPLY CO., INC. · Class I
- Clinical Blood Gas Mixture — Oxarc, LLC · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- Scott Medical Products — AIRGAS USA LLC · Class I
- Scott Medical Products — AIRGAS USA LLC · Class I
- Clinical Blood Gas — MIDDLESEX GASES & TECHNOLOGIES, INC. · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
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
- Industrial Source
Sources (1)
- FDA UDI d703c898-be79-42a7-bbde-31c013f3b970 33 fields · synced Jun 6, 2026