AccessGUDID - DEVICE: VOCSN High Flow Kit (00850018761109)

GUDID

Device Identifier (DI) Information

Brand Name: VOCSN High Flow Kit
Version or Model: 5-Week High Flow Nasal Cannula Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRT-01305-000
Company Name: VENTEC LIFE SYSTEMS, INC.

Primary DI Number: 00850018761109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078758082 *Terms of Use

Device 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)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47083	Portable electric ventilator	A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, Continuous, Facility Use
NOU	Continuous, Ventilator, Home Use
NHJ	Device, Positive Pressure Breathing, Intermittent
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -13 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f329692-c54a-4a93-88bd-f08c321b7656
Public Version Date: March 03, 2021
Public Version Number: 1
DI Record Publish Date: February 23, 2021