Vyaire 2009109-005
Vyaire 2009109-005 is a Class II device made by Airlife, Inc., cleared under FDA 510(k) K020003 on 7 Nov 2002 and listed in FDA GUDID since 15 Nov 2018 (UDI-DI 08809083941642), 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 | Number08809083941642 | Date15 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020003 | Date7 Nov 2002 | StatusActive |
Official records
- AccessGUDID record 08809083941642
- FDA 510(k) database K020003
Across registries
- FDA 510(k) K020003 decided 7 Nov 2002 Active
- FDA GUDID UDI-DI 08809083941642 listed 15 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K020003
- Listed FDA GUDID 08809083941642
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vyaire
- Generic name
- Electrocardiographic electrode, single-use
- Model / reference
- 2009109-005
- Primary DI / UDI-DI
- 08809083941642
- 510(k) Number
- FDA product code
- DRX
- GMDN term
- Electrocardiographic electrode, single-use
- Device class
- Class II
- Regulation number
- 870.2360
- GUDID distribution status
- In Commercial Distribution
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