Identity
- Trade Name
- VOCSN High Flow Kit FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- The Ventec High Flow Nasal Cannula Kit contains the following items: - 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235) - 5x Humidifier Bypass (00855573007136) - 5x Optiflow+ Adult Cannula, Medium (09420012429117) - 5x Auto-fill Disposable Adult Humidification Chamber (09420012432025) - 1x High Pressure O2 Hose (14896138006587) - 1x Temperature Probe (09420012401311) - 1x 850 Heater Wire Adapter (09420012421548) - 1x Water Bag Pole (09420012405920) - 1x MR850 Heated Humidifier (09420012407290) FDA UDI
- Model / Reference
- 5-Week High Flow Nasal Cannula Kit FDA UDI
- Description
- The Ventec High Flow Nasal Cannula Kit contains the following items: - 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235) - 5x Humidifier Bypass (00855573007136) - 5x Optiflow+ Adult Cannula, Medium (09420012429117) - 5x Auto-fill Disposable Adult Humidification Chamber (09420012432025) - 1x High Pressure O2 Hose (14896138006587) - 1x Temperature Probe (09420012401311) - 1x 850 Heater Wire Adapter (09420012421548) - 1x Water Bag Pole (09420012405920) - 1x MR850 Heated Humidifier (09420012407290) FDA UDI
Identifiers
- Catalog Number
- PRT-01264-000 FDA UDI
- Primary DI / UDI-DI
- 00850018761031 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDINHJ FDA UDIBZE FDA UDIBTT 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 UDI868.5450 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
Yes
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
MR Unsafe FDA UDI
Category: Portable electric ventilator
VOCSN High Flow Kit by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 acefbf33-e1e9-4aa2-87ad-150688cbbd9f 35 fields · synced May 30, 2026