Identity
- Trade Name
- Scott Medical Products FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: EL; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions. FDA UDI
- Model / Reference
- Pulmonary Function Gas FDA UDI
- Description
- Description: 0.3% CO, 10% He, 21% O2, Bal. N2; Cylinder: EL; Valve: CGA 973; For use with Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions. FDA UDI
Identifiers
- Catalog Number
- Z04NI685EA0033 FDA UDI
- Primary DI / UDI-DI
- 00819601020412 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Carbon monoxide breath analyser 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
No
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 — 620 Liter FDA UDIPressure — 2000 Pound per Square Inch FDA UDI
Category: Carbon monoxide breath analyser
Scott Medical Products 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 403a2366-3bed-45ca-b81f-ad440511fb19 37 fields · synced May 30, 2026