Identity
- Trade Name
- Calibration Gas Mixture FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, calibrator FDA UDI
- Device Name
- Used to calibrate various medical analyzers and other medical equipment. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Used to calibrate various medical analyzers and other medical equipment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009502024 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 Gas Mixture by Roberts Oxygen Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Roberts Oxygen Co., Inc.
Sources (1)
- FDA UDI 1d4fe9c1-8081-4b17-88e9-f5e6c2b30c7d 33 fields · synced May 30, 2026