Identity
- Trade Name
- VOCSN Power Supply FDA UDI
- Generic Name
- Emergency airway clearance suction system, electric FDA UDI
- Device Name
- VOCSN Power Supply FDA UDI
- Model / Reference
- PRT-00990-000 FDA UDI
- Description
- VOCSN Power Supply FDA UDI
Identifiers
- Catalog Number
- PRT-00990-000 FDA UDI
- Primary DI / UDI-DI
- 00855573007389 FDA UDI
- 510(k) Number
- K162877 FDA UDI
- FDA Product Code
- BTA FDA UDINHJ FDA UDICAW FDA UDICBK FDA UDINOU FDA UDI
- GMDN Term
- Emergency airway clearance suction system, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI868.5905 FDA UDI868.5440 FDA UDI868.5895 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Portable electric ventilatorMobile/portable oxygen concentratorEmergency airway clearance suction system, electricIn-exsufflator
VOCSN Power Supply by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162877 also covers:
- Internal Battery PM Upgrade USB Drive — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, INC.
- VOCSN — VENTEC LIFE SYSTEMS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ventec Life Systems, Inc.
Sources (1)
- FDA UDI b146447e-4a5a-4fa6-bb1f-2df59dfe2280 35 fields · synced May 31, 2026