FDA.reportPublic FDA data

VRV-II Vacuum Relief Valve

Primary DI
10634624431031
Brand
VRV-II Vacuum Relief Valve
Company
QUEST MEDICAL INC
Model
4003103
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWDSuction Control, Intracardiac, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWDSuction Control, Intracardiac, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624431038PackageGS150In Commercial Distribution
10634624431031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462443103820634624431038
1063462443103110634624431031

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system valve, unidirectional flow/pressure controlA sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device.

Regulatory Flags#

DUNS number
041810693
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006346240906516" (15 cm) Microbore Extension Set with Clamp90652017-02-13
006346240925017 in (18cm) Y-Extension Set w/ 2 check valves925092502016-07-26
0063462409541044 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site954195412016-07-26
00634624095434Q2 Checkmate Extension Set95432016-06-10
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
00634624621039Precision Delivery IV Extension SetPDM602021-02-05
00634624621046Precision Delivery IV Extension SetPDM60F2021-02-05
00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621077Precision Delivery IV Extension SetPDV062021-02-05
00634624621084Precision Delivery IV Extension SetPDV06F2021-02-05
00634624621091Precision Delivery IV Extension SetPDV602021-02-05
00634624621107Precision Delivery IV Extension SetPDV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05
00634624621121Precision Delivery Trifurcated IV Extension SetPDT05DF2021-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10634624441030VRV-IIC Clear Vacuum Relief ValveQUEST MEDICAL INCDWD2017-09-29
00634624413122"RLV-2100 ""B"" Vacuum Relief Valve"QUEST MEDICAL INCDWD2017-09-29
00634624431058RLV-T Suction Control DeviceQUEST MEDICAL INCDWD2017-09-29
20634624413225"RLV-2100""B"" Vacuum Relief Valve"QUEST MEDICAL INCDWD2017-09-29
20634624413256RLV-T Suction Control Device_NonsterileQUEST MEDICAL INCDWD2017-09-29
20634624413126RLV-2100 "B" Vacuum Relief ValveQUEST MEDICAL INCDWD2017-09-29
20634624431052RLV-T Suction Control DeviceQUEST MEDICAL INCDWD2017-09-29
10634624432038VRV-II Vacuum Relief ValveQUEST MEDICAL INCDWD2017-09-22
10634624442037VRV-II Clear Vacuum Relief Valve - NonsterileQUEST MEDICAL INCDWD2017-09-22