MaxFlo2 Mini R223P14
by Maxtec, Inc.
MaxFlo2 Mini R223P14 is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K113232 on 1 Mar 2012 and listed in FDA GUDID since 14 Jan 2019 (UDI-DI 00817770021827), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817770021827 | Date14 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113232 | Date1 Mar 2012 | StatusActive |
Official records
- AccessGUDID record 00817770021827
- FDA 510(k) database K113232
Across registries
- FDA 510(k) K113232 decided 1 Mar 2012 Active
- FDA GUDID UDI-DI 00817770021827 listed 14 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K113232
- Listed FDA GUDID 00817770021827
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MaxFlo2 Mini
- Generic name
- Oxygen/air breathing gas mixer, hospital
- Model / reference
- R223P14
- Primary DI / UDI-DI
- 00817770021827
- 510(k) Number
- FDA product code
- BZR
- GMDN term
- Oxygen/air breathing gas mixer, hospital
- Device class
- Class II
- Regulation number
- 868.5330
- GUDID distribution status
- In Commercial Distribution
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