Care-e-vac Plus - Reusable jar
by Hersill Sl
Care-e-vac Plus - Reusable jar (5320214) is an emergency airway clearance suction system (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Hersill Sl, cleared under FDA 510(k) K093241 on 27 Apr 2010 and listed in FDA GUDID since 17 Jan 2025 (UDI-DI 08435510678678), 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 | Number08435510678678 | Date17 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093241 | Date27 Apr 2010 | StatusActive |
Official records
- AccessGUDID record 08435510678678
- FDA 510(k) database K093241
Across registries
- FDA 510(k) K093241 decided 27 Apr 2010 Active
- FDA GUDID UDI-DI 08435510678678 listed 17 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K093241
- Listed FDA GUDID 08435510678678
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Care-E-Vac
- Generic name
- Emergency airway clearance suction system, electric
- Model / Ref / Catalog
- Care-e-vac Plus - Reusable jar, 5320214
- Primary DI / UDI-DI
- 08435510678678
- 510(k) Number
- FDA product code
- BTA
- GMDN term
- Emergency airway clearance suction system, electric
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
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