Identity
- Trade Name
- V-Vac starter kit FDA UDI
- Generic Name
- Emergency airway clearance suction system, manual FDA UDI
- Device Name
- The V-Vac Suction Unit is a manual portable unit designed to provide quick and effective suction. Fully assembled, it weighs less than one pound (0,45 kg) and can be adjusted to accomodate different hand sizes or to provide a range of suction pressures from no more than ~170mmHg up to ~380mmHg. FDA UDI
- Model / Reference
- 985000 FDA UDI
- Description
- The V-Vac Suction Unit is a manual portable unit designed to provide quick and effective suction. Fully assembled, it weighs less than one pound (0,45 kg) and can be adjusted to accomodate different hand sizes or to provide a range of suction pressures from no more than ~170mmHg up to ~380mmHg. FDA UDI
Identifiers
- Catalog Number
- 985000 FDA UDI
- Primary DI / UDI-DI
- 07045430014930 FDA UDI
- 510(k) Number
- K862875 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Emergency airway clearance suction system, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
V-Vac starter kit by Laerdal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (1)
- FDA UDI c26f017d-bf20-4099-8e45-053d0f742cf0 38 fields · synced Jun 8, 2026