DEVICE: VOCSN High Flow Kit (00850018761109)
Device Identifier (DI) Information
VOCSN High Flow Kit
5-Week High Flow Nasal Cannula Kit
In Commercial Distribution
PRT-01305-000
VENTEC LIFE SYSTEMS, INC.
5-Week High Flow Nasal Cannula Kit
In Commercial Distribution
PRT-01305-000
VENTEC LIFE SYSTEMS, INC.
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
MR Unsafe | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -13 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0f329692-c54a-4a93-88bd-f08c321b7656
March 03, 2021
1
February 23, 2021
March 03, 2021
1
February 23, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined