FDA.reportPublic FDA data

RLV-T Suction Control Device_Nonsterile

Primary DI
20634624413256
Brand
RLV-T Suction Control Device_Nonsterile
Company
QUEST MEDICAL INC
Model
4103205
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
20634624413256PrimaryGS10
00634624413252Unit of UseGS10
90634624413256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462441325620634624413256
00634624413252006346244132526346244132520634624413252
9063462441325690634624413256

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-800-627-0226Custserv@questmedical.com

Regulatory Flags#

DUNS number
041810693
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10634624100616Tie-V Securement DeviceQIVB00602022-12-15
00634624417021Lyka® PORT Needle Free Access Device4170Y2025-06-12
20634624533039Vessel Cannula, 3mmVCC-03VCC-032016-06-07
00634624031500Q2® Needleless injection site 315031502017-03-09
20634624100606Qlinch Securement BandQSB00602020-04-08
20634624530380MPS 3 ISO Medical Air Hose Kit5303010-CA2023-10-16
00634624096523Checkmate IV Administration Set 123in (312 cm)965296522016-07-29
20634624530397MPS 3 Drug Pump Cover53030312023-03-24
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624911048High-Flow Extension SetHF01352022-12-12
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624921092High-Flow 4-Way StopcockSTV022022-12-06
00634624921108High-Flow 4-Way StopcockSTV032022-12-06
00634624921160High-Flow 4-Way StopcockST012022-12-06
00634624921191High-Flow 4-Way StopcockST032022-12-06
00634624921207Q2 Blood Administration SetYV1152022-12-06
00634624921214Q2 Blood Administration SetYV1302022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10634624431031VRV-II Vacuum Relief ValveQUEST MEDICAL INCDWD2017-09-29
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
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