Identity
- Trade Name
- VOCSN External Bacterial Filter FDA UDI
- Generic Name
- In-exsufflator FDA UDI
- Device Name
- VOCSN External Bacterial Filter FDA UDI
- Model / Reference
- PRT-00790-001 FDA UDI
- Description
- VOCSN External Bacterial Filter FDA UDI
Identifiers
- Catalog Number
- PRT-00790-003 FDA UDI
- Primary DI / UDI-DI
- 00855573007013 FDA UDI
- 510(k) Number
- K162877 FDA UDI
- FDA Product Code
- CAH FDA UDINHJ FDA UDINOU FDA UDICBK FDA UDI
- GMDN Term
- In-exsufflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI868.5905 FDA UDI868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Portable electric ventilatorIn-exsufflator
VOCSN External Bacterial Filter 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 727cba0f-7b59-4faf-a59a-faf6b09c76a6 35 fields · synced May 30, 2026