Identity
- Trade Name
- CARE-E-VAC FDA UDI
- Generic Name
- Emergency airway clearance suction system, electric FDA UDI
- Device Name
- V7 G: Care-e-vac Plus C/I with reusable jar FDA UDI
- Model / Reference
- Care-e-vac C/I - Reusable jar FDA UDI
- Description
- V7 G: Care-e-vac Plus C/I with reusable jar FDA UDI
Identifiers
- Catalog Number
- 5320212 FDA UDI
- Primary DI / UDI-DI
- 08435510678661 FDA UDI
- 510(k) Number
- K093241 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Emergency airway clearance suction system, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Emergency airway clearance suction system, electric
Care-E-Vac by Hersill Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Emergency airway clearance suction system, electric.
- SSCOR Duet ® — SSCOR, INC. · Class II
- VOCSN — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN — VENTEC LIFE SYSTEMS, INC. · Class II
- VOCSN Fan Filters — VENTEC LIFE SYSTEMS, INC. · Class II
- SSCOR DUET — SSCOR, INC. · Class II
- SSCOR/board — SSCOR, INC. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- SSCOR QUICKDRAW® — SSCOR, INC. · Class II
Cleared under the same submission
K093241 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hersill Sl
Sources (1)
- FDA UDI e26b143b-688a-4bd7-a039-0621f362f021 35 fields · synced Jun 1, 2026