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V-VAC Manual Suction Unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 985300Model V-VAC Manual Suction Unit
Identity
- Trade Name
- V-VAC Manual Suction Unit EUDAMEDV-Vac Starter kit w/out Catheter FDA UDI
- Generic Name
- Emergency airway clearance suction system, manual FDA UDI
- Device Name
- V-VAC Manual Suction Unit EUDAMEDThe 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
- V-VAC Manual Suction Unit EUDAMED985300 EUDAMEDFDA 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
- 985300 FDA UDI
- Primary DI / UDI-DI
- 07045432106374 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209942SY EUDAMED
- Direct Marketing DI
- 07045432106374 EUDAMED
- 510(k) Number
- K862875 FDA UDI
- FDA Product Code
- BTA FDA UDI
- EMDN Code
- R05010101 RESPIRATORY SUCTION PROBES WITHOUT A CONTROL HOLE EUDAMED
- GMDN Term
- Emergency airway clearance suction system, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Manual Suction Unit by Laerdal Medical AS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0704543209942SY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (2)
- EUDAMED 54f20b32-5c15-4053-9d9d-836118c62531 61 fields · synced Jul 26, 2026
- FDA UDI 2b13d85d-8353-4e9b-b86a-f0bebdb080b0 37 fields · synced May 29, 2026