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

Duns Number:090508636

Device Description: The GO2VENT provides constant fl ow, pressure cycled ventilatory support in either pressur The GO2VENT provides constant fl ow, 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 fl ow, 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 aff ect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the fi nal adjustments are made in a secured position (strapped or taped to the patient).

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More Product Details

Catalog Number

6001

Brand Name

VORTRAN GO2VENT

Version/Model Number

6001

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

2af00251-5778-4f97-857b-c0270147968d

Public Version Date

October 16, 2019

Public Version Number

2

DI Record Publish Date

May 03, 2019

Additional Identifiers

Package DI Number

20637320060014

Quantity per Package

10

Contains DI Package

10637320060017

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