VORTRAN GO2VENT with PEEP Valve 6200

GUDID 20637320062001

The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

VORTRAN MEDICAL TECHNOLOGY 1, INC

Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use
Primary Device ID20637320062001
NIH Device Record Key22a62c4d-6456-40be-8f06-0fed3d5fb714
Commercial Distribution StatusIn Commercial Distribution
Brand NameVORTRAN GO2VENT with PEEP Valve
Version Model Number6200
Catalog Number6200
Company DUNS090508636
Company NameVORTRAN MEDICAL TECHNOLOGY 1, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com
Phone(800) 434-4034
Emailinfo@vortran.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110637320062004 [Primary]
GS120637320062001 [Package]
Contains: 10637320062004
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, Emergency, Powered (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-12
Device Publish Date2021-05-04

Devices Manufactured by VORTRAN MEDICAL TECHNOLOGY 1, INC

20637320062001 - VORTRAN GO2VENT with PEEP Valve2021-05-12The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.
20637320062001 - VORTRAN GO2VENT with PEEP Valve2021-05-12 The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow,
10637320039600 - VORTRAN® APM-Plus2020-02-07 The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for m
20637320060014 - VORTRAN GO2VENT2019-05-13 The GO2VENT provides constant flow, ­pressure cycled ventilatory support in ­either pressure control or ­pressure support mo
10637320000112 - VORTRAN GO2VENT 2019-04-29 The GO2VENT provides constant fl ow, pressure cycled ventilatory support in either pressure control or pressure support modes on
20637320035005 - VAR-Monitor2018-07-06 The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient contact during its operation. If the V
20637320039003 - VORTRAN Airway Pressure Monitor2018-07-06 The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via th
20637320040702 - E-Surge Kit2018-06-12 Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 each Multi-outlet manifold; 1 each 20
20637320050503 - VAR Surgical Center Kit2018-06-12 Kit Contains: 3 each VAR Model PCM-5011; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung

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