PAHI VersalVent

GUDID 04719872000006

The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient br

PAN-AMERICA HYPERBARICS INC.

Portable pneumatic ventilator
Primary Device ID04719872000006
NIH Device Record Key8607f4b5-4fa4-49dc-88a5-360fe9796e9b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePAHI VersalVent
Version Model NumberModel V1
Company DUNS658755160
Company NamePAN-AMERICA HYPERBARICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(972)4230377
Emailservice@panamericahbo.com

Device Dimensions

Height241.3 Millimeter
Width203.2 Millimeter
Length304.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872000006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-10
Device Publish Date2015-10-10

Devices Manufactured by PAN-AMERICA HYPERBARICS INC.

04719872000006 - PAHI VersalVent 2018-07-10The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient br
04719872000006 - PAHI VersalVent 2018-07-10 The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any oth
04719872000013 - PAHI PAH-S1 Monoplace Hyperbaric Chamber2018-07-10 The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum

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