VRV-II Vacuum Relief Valve

GUDID 10634624432038

Bulk, non-sterile VRV-II Vacuum Relief Valve. Contains 50 non-sterile valves. The sterile version is Model 4003103.

QUEST MEDICAL INC

Cardiopulmonary bypass system valve, unidirectional flow/pressure control
Primary Device ID10634624432038
NIH Device Record Keyf30c8df8-b169-435d-8f6c-c8b126880596
Commercial Distribution StatusIn Commercial Distribution
Brand NameVRV-II Vacuum Relief Valve
Version Model Number4003203
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624432031 [Unit of Use]
GS110634624432038 [Primary]
GS120634624432035 [Package]
Package: Box [2 Units]

FDA Product Code

DWDSuction Control, Intracardiac, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10634624432038]

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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