Aira 100534
by Aira, LLC
Aira 100534 is a Class II device made by Aira, LLC, cleared under FDA 510(k) K071886 on 27 Dec 2007 and listed in FDA GUDID since 10 Feb 2026 (UDI-DI 00810194400650), 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 | Number00810194400650 | Date10 Feb 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071886 | Date27 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 00810194400650
- FDA 510(k) database K071886
Across registries
- FDA 510(k) K071886 decided 27 Dec 2007 Active
- FDA GUDID UDI-DI 00810194400650 listed 10 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K071886
- Listed FDA GUDID 00810194400650
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aira
- Generic name
- Sterilization packaging, single-use
- Model / reference
- 100534
- Primary DI / UDI-DI
- 00810194400650
- 510(k) Number
- FDA product code
- FRG
- GMDN term
- Sterilization packaging, single-use
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
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