FDA.reportPublic FDA data

MPS Back Up System, front crank

Primary DI
20634624510214
Brand
MPS Back Up System, front crank
Company
QUEST MEDICAL INC
Model
5001021
Device description
MPS Back Up System, front crank, blood only
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002366000QUEST MPS BACK-UP SYSYEMQuest Medical, Inc.2000-09-18DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624510214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462451021420634624510214

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heat exchanger, reusableA device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
041810693
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20634624530380MPS 3 Medical Air Hose Kit5303010-CA2023-10-16
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
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
00199150083855NAMEDTRONIC, INC.DWF2026-06-08
00199150083992NAMEDTRONIC, INC.DWF2026-06-08
00199150084180NAMEDTRONIC, INC.DWF2026-06-08
00824846000020NAMEDTRONIC, INC.DWF2026-06-08
00824846000983NAMEDTRONIC, INC.DWF2026-06-08
00824846001027NAMEDTRONIC, INC.DWF2026-06-08
00824846001041NAMEDTRONIC, INC.DWF2026-06-08
00824846001065NAMEDTRONIC, INC.DWF2026-06-08
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30
00199150083800NAMEDTRONIC, INC.DWF2026-05-30
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11