Identity
- Trade Name
- MediSourceNet, Inc FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc) FDA UDI
- Model / Reference
- KWV-M FDA UDI
- Description
- KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850034735009 FDA UDI
- 510(k) Number
- K192035 FDA UDI
- FDA Product Code
- FYD FDA UDI
- GMDN Term
- Surgical plume evacuation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5070 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
No
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: Surgical plume evacuation system
MediSourceNet, Inc by Medisourcenet, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192035 also covers:
- MediMax Tech — MEDIMAX TECH INC.
- MediMax Tech — MEDIMAX TECH INC.
- MediMax Tech — MEDIMAX TECH INC.
- MediMax Tech — MEDIMAX TECH INC.
- MediMax Tech — MEDIMAX TECH INC.
- MediMax Tech — MEDIMAX TECH INC.
- MediSourceNet, Inc — Medisourcenet, Inc
- MediSourceNet, Inc — Medisourcenet, Inc
- MediSourceNet, Inc — Medisourcenet, Inc
- MediSourceNet, Inc — Medisourcenet, Inc
- MediSourceNet, Inc — Medisourcenet, Inc
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
- Medisourcenet, Inc
Sources (1)
- FDA UDI abd84dfe-d995-42aa-a4e5-38709d3257a8 35 fields · synced May 30, 2026