Drive 18081
Drive 18081 is a Class II device made by Drive Devilbiss Healthcare, cleared under FDA 510(k) K003344 on 15 Mar 2001 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00822383504131), 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 | Number00822383504131 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK003344 | Date15 Mar 2001 | StatusActive |
Official records
- AccessGUDID record 00822383504131
- FDA 510(k) database K003344
Across registries
- FDA 510(k) K003344 decided 15 Mar 2001 Active
- FDA GUDID UDI-DI 00822383504131 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K003344
- Listed FDA GUDID 00822383504131
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Drive
- Generic name
- Therapeutic agent nebulizer, benchtop
- Model / reference
- 18081
- Primary DI / UDI-DI
- 00822383504131
- 510(k) Number
- FDA product code
- BTI, CAF
- GMDN term
- Therapeutic agent nebulizer, benchtop
- Device class
- Class II
- Regulation number
- 868.6250, 868.5630
- GUDID distribution status
- In Commercial Distribution
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