VAR Surgical Center Kit PCK-5050

GUDID 20637320050503

Kit Contains: 3 each VAR Model PCM-5011; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung

VORTRAN MEDICAL TECHNOLOGY 1, INC

Pulmonary resuscitator, pneumatic, single-use Pulmonary resuscitator, pneumatic, single-use
Primary Device ID20637320050503
NIH Device Record Keybc83ae77-e008-45fe-b9ff-9981ce7cbf4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVAR Surgical Center Kit
Version Model NumberPCK-5050
Catalog NumberPCK-5050
Company DUNS090508636
Company NameVORTRAN MEDICAL TECHNOLOGY 1, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(916) 648-8460
Emaillweddington@vortran.com
Phone(916) 648-8460
Emaillweddington@vortran.com

Device Identifiers

Device Issuing AgencyDevice ID
GS120637320050503 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-12
Device Publish Date2016-07-14

Devices Manufactured by VORTRAN MEDICAL TECHNOLOGY 1, INC

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 Kit2018-06-12Kit Contains: 3 each VAR Model PCM-5011; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung
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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