Lung Diffusion Test Mixture 1
Lung Diffusion Test Mixture 1 is a Class I device made by Red Ball Oxygen Company, listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00860009625914), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860009625914 | Date8 Dec 2022 | StatusListed |
Official records
- AccessGUDID record 00860009625914
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Lung Diffusion Test Mixture
- Generic name
- Carbon monoxide breath analyser
- Model / reference
- 1
- Primary DI / UDI-DI
- 00860009625914
- FDA product code
- BXK
- GMDN term
- Carbon monoxide breath analyser
- Device class
- Class I
- Regulation number
- 868.6400
- GUDID distribution status
- In Commercial Distribution
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