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VOCSN High Flow Kit

FDA UDI

Class II (US FDA UDI)

by Ventec Life Systems, Inc.

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 UDI
NOU FDA UDI
NHJ FDA UDI
BZE FDA UDI
BTT FDA UDI
GMDN Term
Portable electric ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
868.5905 FDA UDI
868.5270 FDA UDI
868.5450 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
MRI Safety
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

Similar devices

Also classified as Portable electric ventilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI acefbf33-e1e9-4aa2-87ad-150688cbbd9f 35 fields · synced May 30, 2026