VRV-II Clear Vacuum Relief Valve - Nonsterile 4004203

GUDID 10634624442037

QUEST MEDICAL INC

Cardiopulmonary bypass system valve, unidirectional flow/pressure control
Primary Device ID10634624442037
NIH Device Record Key4d2e593e-6650-4955-966f-1dafbdab70b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVRV-II Clear Vacuum Relief Valve - Nonsterile
Version Model Number4004203
Catalog Number4004203
Company DUNS041810693
Company NameQUEST MEDICAL INC
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624442030 [Unit of Use]
GS110634624442037 [Primary]
GS120634624442034 [Package]
Package: Box [2 Units]
In Commercial Distribution

FDA Product Code

DWDSuction Control, Intracardiac, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10634624442037]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-13
Device Publish Date2017-09-22

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