FDA.reportPublic FDA data

Cardiotomy reservoir

Definition
A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.
GUDID devices
165
Last updated
2026-07-17 22:01:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08033178109673CARDIOTOMY RESERVOIRSORIN GROUP ITALIA SRLUNFILTERED2015-07-15
08033178112291INSPIRESORIN GROUP ITALIA SRLHVR2015-05-13
08033178112307INSPIRESORIN GROUP ITALIA SRLHVR DUAL2015-05-13
08033178113014INSPIRESORIN GROUP ITALIA SRLSVR 12002017-03-29
00613994269775Minimax Plus®MEDTRONIC, INC.33012015-06-09
00613994269782Minimax®MEDTRONIC, INC.13162015-06-09
00613994529084Intersept®MEDTRONIC, INC.CB13512015-06-09
00613994617255Affinity Pixie™MEDTRONIC, INC.CBP2412015-06-16
00613994617309Affinity Pixie™MEDTRONIC, INC.BBP2412016-06-02
00613994842909NAMEDTRONIC, INC.EL21202016-06-16
00613994842923NAMEDTRONIC, INC.EL4002016-06-24
00613994842930NAMEDTRONIC, INC.EL4022016-07-23
00613994842947NAMEDTRONIC, INC.EL4042016-06-24
00613994930996MVR®MEDTRONIC, INC.MVR8002016-06-17
00613994931009MVR®MEDTRONIC, INC.MVR16002016-06-16
00613994931016MVR®MEDTRONIC, INC.CBMVR8002016-06-17
00613994931023MVR®MEDTRONIC, INC.CBMVR16002016-06-16
00643169767522MVR™MEDTRONIC, INC.CBMVR8002016-12-31
00643169767546MVR™MEDTRONIC, INC.CBMVR16002016-12-31
00643169767560MVR™MEDTRONIC, INC.MVR16002016-12-31
00643169767584MVR™MEDTRONIC, INC.MVR8002016-12-31
00643169767607Intersept™MEDTRONIC, INC.CB13512017-03-04
00643169767645Intersept™MEDTRONIC, INC.13512017-02-05
00643169785816Affinity Pixie™MEDTRONIC, INC.CBP2412017-02-28
00650862100044OCEANAtrium Medical Corporation2002-0502015-09-24
00650862103014OCEANAtrium Medical Corporation2050-0002015-09-24
00650862103038OCEANAtrium Medical Corporation2050-0702015-09-24
00650862103069OCEANAtrium Medical Corporation2050-3002015-09-24
00650862104011OCEANAtrium Medical Corporation2052-0002015-09-24
00650862104035OCEANAtrium Medical Corporation2052-3002015-09-24
00650862110036OASISAtrium Medical Corporation3600-1502015-09-24
00650862113013OASISAtrium Medical Corporation3650-1002015-09-24
00650862114010OASISAtrium Medical Corporation3652-1002015-09-24
00650862115147EXPRESSAtrium Medical Corporation4050-100N2015-09-24
00650862115161EXPRESSAtrium Medical Corporation4050-170N2015-09-24
00673978523576NAMEDTRONIC, INC.EL4002016-06-16
00673978523583NAMEDTRONIC, INC.EL4022016-06-24
00673978523590NAMEDTRONIC, INC.EL4042016-06-16
00673978537184Intersept®MEDTRONIC, INC.13512015-06-09
00673978562773Intersept®MEDTRONIC, INC.CB13512015-06-09
00699753450165Capiox® Hardshell ReservoirTerumo Cardiovascular Systems CorporationCX*SXRX2015-10-02
00699753450196Capiox® Flexible Venous ReservoirTerumo Cardiovascular Systems Corporation3CXFVR1500X2016-10-06
00699753450202Capiox® Flexible Venous ReservoirTerumo Cardiovascular Systems Corporation3CXFVR1500XC2016-10-06
00699753450394Capiox® Hardshell ReservoirTerumo Cardiovascular Systems CorporationCX*CRXA2015-10-02
00699753450776Capiox® Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*R4000C2016-01-20
04037691064819NAMaquet Cardiopulmonary AGVenous Reservoir Bag 1900 ml2015-10-24
04037691740348NAMaquet Cardiopulmonary AGVenous Reservoir Bag 800 ml2015-10-24
04037692010006QUADROX-iMaquet Cardiopulmonary AGSmall Adult, reservoir2015-12-15
04987350706393CAPIOX® VENOUS RESERVOIRTERUMO CORPORATIONCX*VRA0101T22015-09-15
04987350706492CAPIOX® VENOUS RESERVOIRTERUMO CORPORATIONCX*VRA0401T22015-09-15
04987350706591CAPIOX® VENOUS RESERVOIRTERUMO CORPORATIONCX*VRA0701T22015-09-15
04987350706690CAPIOX® VENOUS RESERVOIRTERUMO CORPORATIONCX*VRA1001T22015-09-15
08033178109550BMRSORIN GROUP ITALIA SRL1900L PH.I.S.I.O.2015-07-15
08033178109611KIDSSORIN GROUP ITALIA SRLD120 R PHISIO2015-05-13
08033178113144INSPIRESORIN GROUP ITALIA SRLHCR DUAL2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLHCR2026-01-16
08033178114158BMRSORIN GROUP ITALIA SRL1900 PH.I.S.I.O.2023-10-05
08033178250122RESERVOIRSORIN GROUP ITALIA SRLCARD 43 + ADAPTOR2016-09-15
08033178250160RESERVOIRSORIN GROUP ITALIA SRLD744 D.A.C.2015-07-15
08033178250221RESERVOIRSORIN GROUP ITALIA SRLD920 DIDECO LILLIPUT R2015-07-15
08033178250252RESERVOIRSORIN GROUP ITALIA SRLD764 DIDECO MIDICARD2015-07-15
08033178250276RESERVOIRSORIN GROUP ITALIA SRLD754 DIDECO VENOMIDICARD2015-07-15
08033178250283RESERVOIRSORIN GROUP ITALIA SRLD970 DIDECO AVANT R2015-07-15
08033178250313RESERVOIRSORIN GROUP ITALIA SRLSYNTHESIS R + ADAPTORS2016-09-15
08033178250375CARDIOTOMY RESERVOIRSORIN GROUP ITALIA SRLFILTERED2015-07-15
08033178250382BMRSORIN GROUP ITALIA SRL1900 PH.I.S.I.O.2015-07-15
38033178113145INSPIRESORIN GROUP ITALIA SRLHCR DUAL2026-01-16
38033178113152INSPIRESORIN GROUP ITALIA SRLHCR2026-01-16
18051160302724Quantum Perfusion Hybrid SystemSPECTRUM MEDICAL SRLHR04V-A02024-08-06
08033178114165BMRSORIN GROUP ITALIA SRL1900L PH.I.S.I.O.2023-10-05
38033178114159BMRSORIN GROUP ITALIA SRL1900 PH.I.S.I.O.2023-10-05
20613994269779Minimax Plus®MEDTRONIC, INC.33012015-06-09
20613994269786Minimax®MEDTRONIC, INC.13162015-06-09
20613994529088Intersept®MEDTRONIC, INC.CB13512015-06-09
20613994617259Affinity Pixie™MEDTRONIC, INC.CBP2412015-06-16
20613994617303Affinity Pixie™MEDTRONIC, INC.BBP2412016-06-02
20613994842903NAMEDTRONIC, INC.EL21202016-06-16
20613994842927NAMEDTRONIC, INC.EL4002016-06-24
20613994842934NAMEDTRONIC, INC.EL4022016-07-23
20613994842941NAMEDTRONIC, INC.EL4042016-06-24