Identity
- Trade Name
- VOCSN FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- V+C, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com FDA UDI
- Model / Reference
- V+C, Japanese FDA UDI
- Description
- V+C, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com FDA UDI
Identifiers
- Catalog Number
- PRT-01098-1XX FDA UDI
- Primary DI / UDI-DI
- 00850018761116 FDA UDI
- 510(k) Number
- K162877 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDINHJ FDA UDIBZE FDA UDICAH FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI868.5905 FDA UDI868.5270 FDA UDI868.5260 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
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
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 ventilatorIn-exsufflator
Vocsn by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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K162877 also covers:
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- 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 d2999a92-24d2-4505-bbcb-0320cd3f411c 36 fields · synced May 30, 2026