Identity
- Trade Name
- Cosmed USA FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, calibrator FDA UDI
- Device Name
- Description: 5% CO2, 16% O2, BAL. N2; Cylinder: ED; Valve: CGA 973; For calibration of medical analyzers in accordance with manufacturer's instructions. Manufactured for Cosmed USA.; Cosmed Part#: A-860-000-004. FDA UDI
- Model / Reference
- Calibration Gas FDA UDI
- Description
- Description: 5% CO2, 16% O2, BAL. N2; Cylinder: ED; Valve: CGA 973; For calibration of medical analyzers in accordance with manufacturer's instructions. Manufactured for Cosmed USA.; Cosmed Part#: A-860-000-004. FDA UDI
Identifiers
- Catalog Number
- Z03NI798EDC001 FDA UDI
- Primary DI / UDI-DI
- 00819601021150 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 560 Liter FDA UDIPressure — 2200 Pound per Square Inch FDA UDI
Category: Multiple blood gas analyte IVD, calibrator
Cosmed USA by Airgas Usa Llc — 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
- Airgas Usa Llc
Sources (1)
- FDA UDI 1c95bda7-e14c-41b2-a801-a56222f152c4 37 fields · synced Jun 1, 2026