Infant Flow™ 777014
Infant Flow™ 777014 is a Class II device made by Vyaire Medical, Inc., cleared under FDA 510(k) K031745 on 13 Feb 2004 and listed in FDA GUDID since 5 Jun 2020 (UDI-DI 10190752184428), active as of 23 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 | Number10190752184428 | Date5 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031745 | Date13 Feb 2004 | StatusActive |
Official records
- AccessGUDID record 10190752184428
- FDA 510(k) database K031745
Across registries
- FDA 510(k) K031745 decided 13 Feb 2004 Active
- FDA GUDID UDI-DI 10190752184428 listed 5 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K031745
- Listed FDA GUDID 10190752184428
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Infant Flow™
- Generic name
- Respiratory oxygen therapy system
- Model / Ref / Catalog
- 777014
- Primary DI / UDI-DI
- 10190752184428
- 510(k) Number
- FDA product code
- BZD
- GMDN term
- Respiratory oxygen therapy system
- Device class
- Class II
- Regulation number
- 868.5905
- GUDID distribution status
- In Commercial Distribution
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