Identity
- Trade Name
- Lung Diffusion Mixture FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Lung Diffusion Mixture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009591820 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
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: Carbon monoxide breath analyser
Lung Diffusion Mixture by Industrial Source — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon monoxide breath analyser.
- CoSense ETCO Monitor — Capnia, Inc. · Class II
- BreathCO — Vitalograph Ireland, Ltd. · Class II
- Scott Medical Products — AIRGAS USA LLC · Class I
- Lung Diffusion — MIDDLESEX GASES & TECHNOLOGIES, INC. · Class I
- Scott Medical Products — AIRGAS USA LLC · Class I
- Vyaire — Jaeger Medical GmbH · Class II
- Lung Diffusion Mixture — Oxarc, LLC · Class I
- Airgas Healthcare — AIRGAS USA LLC · Class I
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
- Industrial Source
Sources (1)
- FDA UDI 353c6dee-232b-4002-ab21-353581dce477 33 fields · synced May 30, 2026