Activ.a.c.™ 340000
Activ.a.c.™ 340000 is a Class II device made by Kci USA, Inc., cleared under FDA 510(k) K063692 on 7 Jun 2007 and listed in FDA GUDID since 1 Aug 2018 (UDI-DI 00849554000285), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00849554000285 | Date1 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK063692 | Date7 Jun 2007 | StatusActive |
Official records
- AccessGUDID record 00849554000285
- FDA 510(k) database K063692
Across registries
- FDA 510(k) K063692 decided 7 Jun 2007 Active
- FDA GUDID UDI-DI 00849554000285 listed 1 Aug 2018 Listed
Recalls
-
- Terminated Z-0665-2010
Power cords may crack and fail inside plug with potential for fire hazard.
Timeline
- Cleared FDA 510(k) K063692
- Recall initiated FDA recalls Z-0665-2010
- Listed FDA GUDID 00849554000285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Activ.a.c.™
- Generic name
- Negative-pressure wound therapy system, battery-powered, reusable
- Model / reference
- 340000
- Primary DI / UDI-DI
- 00849554000285
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy system, battery-powered, reusable
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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