VORTRAN GO2VENT - The GO2VENT provides constant flow, pressure - VORTRAN MEDICAL TECHNOLOGY 1, INC

Duns Number:090508636

Device Description: The GO2VENT provides constant flow, pressure cycled ventilatory support in either pressure The GO2VENT provides constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for safety. The working mechanism of the GO2VENT consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient).

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More Product Details

Catalog Number

6123

Brand Name

VORTRAN GO2VENT

Version/Model Number

6123

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162968,K162968

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

fc3c2a3c-63c3-4fa3-b65d-410debf77ac7

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

June 07, 2017

Additional Identifiers

Package DI Number

20637320000102

Quantity per Package

10

Contains DI Package

10637320000105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VORTRAN MEDICAL TECHNOLOGY 1, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22