FDA.reportPublic FDA data

RLV-2100 "B" Vacuum Relief Valve

Primary DI
20634624413126
Brand
RLV-2100 "B" Vacuum Relief Valve
Company
QUEST MEDICAL INC
Model
4103102
Catalog number
4103102
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20634624413126PackageGS1100In Commercial Distribution
00634624413122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462441312620634624413126
00634624413122006346244131226346244131220634624413122

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

Regulatory Flags#

DUNS number
041810693
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634624531024MPS 3 Delivery Set w/AA w/305cm Line50031022020-07-27
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
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05
00634624901032Q2 IV Administration SetASV103Y2020-06-25
00634624911048High-Flow Extension SetHF01352022-12-12
00634624911062Precision Delivery IV Extension SetPD06F2022-10-26
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624921115High-Flow 4-Way Stopcock ExtensionHFSTV022022-12-05
00634624921245High-Flow 4-Way Stopcock ExtensionHFST012022-11-30
00634624921382Precision Delivery IV Extension SetPDB05CV12022-09-15
00634624921399Precision Delivery IV Extension SetPDB05CV22022-09-15

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
20634624413256RLV-T Suction Control Device_NonsterileQUEST 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