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.
00850018761109
GS1

1
078758082 *Terms of Use
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)
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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
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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)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -13 and 122 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0f329692-c54a-4a93-88bd-f08c321b7656
March 03, 2021
1
February 23, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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