miniFlow 58402
miniFlow 58402 is a Class II device made by Airon Corporation, cleared under FDA 510(k) K121379 on 11 Oct 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00853678006337), 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 | Number00853678006337 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121379 | Date11 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 00853678006337
- FDA 510(k) database K121379
Across registries
- FDA 510(k) K121379 decided 11 Oct 2012 Active
- FDA GUDID UDI-DI 00853678006337 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K121379
- Listed FDA GUDID 00853678006337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- miniFlow
- Generic name
- Nasal oxygen cannula, CPAP
- Model / Ref / Catalog
- 58402
- Primary DI / UDI-DI
- 00853678006337
- 510(k) Number
- FDA product code
- CBK
- GMDN term
- Nasal oxygen cannula, CPAP
- Device class
- Class II
- Regulation number
- 868.5895
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — .50 InchWidth — .25 InchLength — 2.0 InchWeight — .020 Pound
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