VOCSN High Flow Kit PRT-01305-000

GUDID 00850018761109

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)

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator
Primary Device ID00850018761109
NIH Device Record Key0f329692-c54a-4a93-88bd-f08c321b7656
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOCSN High Flow Kit
Version Model Number5-Week High Flow Nasal Cannula Kit
Catalog NumberPRT-01305-000
Company DUNS078758082
Company NameVENTEC LIFE SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018761109 [Primary]

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-03
Device Publish Date2021-02-23

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

00850018761307 - HomeFill® Oxygen System2023-10-24
00850018761352 - HomeFill® Oxygen System2023-10-24
00850018761369 - HomeFill® Oxygen System2023-10-24
00850018761376 - HomeFill® Oxygen System2023-10-24
00855573007822 - VOCSN2023-07-10
00850018761291 - PreciseRx™ Pediatric Flowmeter2023-06-26
00855573007761 - VOCSN2022-04-20 V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory supp
00855573007785 - VOCSN2022-04-20 V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support fo

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.