Asp Aeroflex™ 28000
by Advanced Sterilization Products Services Inc.
Asp Aeroflex™ 28000 is a Class II device made by Advanced Sterilization Products Services Inc., cleared under FDA 510(k) K181472 on 23 Apr 2019 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 10705037048717), 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 | Number10705037048717 | Date31 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181472 | Date23 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 10705037048717
- FDA 510(k) database K181472
Across registries
- FDA 510(k) K181472 decided 23 Apr 2019 Active
- FDA GUDID UDI-DI 10705037048717 listed 31 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K181472
- Listed FDA GUDID 10705037048717
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Asp Aeroflex™
- Generic name
- Instrument non-thermal chemical disinfector
- Model / Ref / Catalog
- 28000
- Primary DI / UDI-DI
- 10705037048717
- 510(k) Number
- FDA product code
- FEB
- GMDN term
- Instrument non-thermal chemical disinfector
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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