Identity
- Trade Name
- VOCSN Carry Bag FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- The VOCSN Carry Bag supports everyday mobility with an included shoulder strap and attachment points for securing VOCSN to a wheelchair, bed rail, and other mounts. The Carry Bag is compatible with the VOCSN Roll Stand, the Travel Suction Canister, and other accessories. It also allows access to both removable, rechargeable batteries during use. FDA UDI
- Model / Reference
- Carry Bag FDA UDI
- Description
- The VOCSN Carry Bag supports everyday mobility with an included shoulder strap and attachment points for securing VOCSN to a wheelchair, bed rail, and other mounts. The Carry Bag is compatible with the VOCSN Roll Stand, the Travel Suction Canister, and other accessories. It also allows access to both removable, rechargeable batteries during use. FDA UDI
Identifiers
- Catalog Number
- PRT-01143-000 FDA UDI
- Primary DI / UDI-DI
- 00855573007815 FDA UDI
- 510(k) Number
- K162877 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable electric ventilator
VOCSN Carry Bag 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 |
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Manufacturer
- Manufacturer
- Ventec Life Systems, Inc.
Sources (1)
- FDA UDI f705c51c-8e0e-43ca-a537-45c1a97b74c1 36 fields · synced May 30, 2026