FDA.reportPublic FDA data

Extracorporeal membrane oxygenator

Definition
A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.
GUDID devices
399
Last updated
2026-10-06 03:50:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04987350739100CAPIOXTERUMO CORPORATIONCX*FX05EA2021-07-01
04987350739124CAPIOXTERUMO CORPORATIONCX*FX05WA2021-07-06
04987350781710CAPIOX®FXTERUMO CORPORATIONCX*FX05E2015-09-15
04987350781734CAPIOX®FXTERUMO CORPORATIONCX*FX05W2015-09-15
08033178112253INSPIRESORIN GROUP ITALIA SRL6M2015-05-13
08033178112277INSPIRESORIN GROUP ITALIA SRL6F M2015-05-13
08033178112284INSPIRESORIN GROUP ITALIA SRL8F M2015-05-13
08033178112352INSPIRESORIN GROUP ITALIA SRL6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRESORIN GROUP ITALIA SRL8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRESORIN GROUP ITALIA SRL6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRESORIN GROUP ITALIA SRL8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRESORIN GROUP ITALIA SRL6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRESORIN GROUP ITALIA SRL8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRESORIN GROUP ITALIA SRL6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRESORIN GROUP ITALIA SRL8F DUAL PH.I.S.I.O.2015-05-13
08033178113182INSPIRESORIN GROUP ITALIA SRL7 M2019-08-28
08033178113212INSPIRESORIN GROUP ITALIA SRL72019-08-28
08033178113236INSPIRESORIN GROUP ITALIA SRL7 DUAL2019-08-28
08033178113342INSPIRESORIN GROUP ITALIA SRL7F M2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRL7F2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRL7F DUAL2021-04-13
06974762681019LifemotionLifemotion Medical Technology Co., Ltd.LM-BGEA-10002026-06-02
06974762682221LifemotionLifemotion Medical Technology Co., Ltd.LMF-13-0012026-06-05
00613994008893ECMOMEDTRONIC, INC.613994008892014-09-23
00613994008916ECMOMEDTRONIC, INC.613994008912014-09-23
00613994375629TRILLIUM® Affinity NT®MEDTRONIC, INC.952162015-06-16
00613994375636TRILLIUM® AFFINITY NT®MEDTRONIC, INC.952172015-09-21
00613994375650Affinity®MEDTRONIC, INC.952142015-06-16
00613994375674AFFINITY®MEDTRONIC, INC.952122015-06-18
00613994529091Affinity®MEDTRONIC, INC.CB5112015-06-16
00613994529107Affinity®MEDTRONIC, INC.CB5412015-06-16
00613994617279Affinity Pixie™MEDTRONIC, INC.CBP2112015-06-16
00613994617316Affinity Pixie™MEDTRONIC, INC.BBP2112015-06-16
00613994865977TRILLIUM® Affinity NT®MEDTRONIC, INC.952152015-06-16
00613994965134MINIMAX®MEDTRONIC, INC.CB33812015-06-09
00643169785793Affinity Pixie™MEDTRONIC, INC.CBP2112017-02-28
00643169802223Affinity NT™MEDTRONIC, INC.CB5412020-05-28
00643169802247Affinity NT™MEDTRONIC, INC.CB5112020-05-28
00673978538402NAMEDTRONIC, INC.1474R12016-06-16
00673978538426NAMEDTRONIC, INC.1475R12016-09-04
00673978546193Minimax Plus®MEDTRONIC, INC.33812015-06-09
00681490008570Affinity®MEDTRONIC, INC.CB5112015-06-16
00681490791106TRILLIUM™ AFFINITY®MEDTRONIC, INC.952152015-06-18
00699753450035Capiox® SX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems CorporationCX*SX18R2015-10-01
00699753450042Capiox® SX Hollow Fiber OxygenatorTerumo Cardiovascular Systems CorporationCX*SX18X2015-10-01
00699753450059Capiox® SX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems CorporationCX*SX18RX2015-10-01
00699753450073Capiox® SX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems CorporationCX*SX25R2015-10-01
00699753450080Capiox® SX Hollow Fiber OxygenatorTerumo Cardiovascular Systems CorporationCX*SX25X2015-10-01
00699753450097Capiox® SX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems CorporationCX*SX25RX2015-10-01
00699753450103Capiox® RX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*RX25RE2015-10-01
00699753450110Capiox® RX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*RX25RW2015-10-01
00699753450127Capiox® RX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*RX15RW302015-10-01
00699753450134Capiox® RX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*RX15RE302015-10-01
00699753450141Capiox® RX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*RX15RW402015-10-01
00699753450158Capiox® RX Hollow Fiber Oxygenator with Hardshell ReservoirTerumo Cardiovascular Systems Corporation3CX*RX15RE402015-10-01
00699753450448Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RE302015-10-01
00699753450455Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RE402015-10-01
00699753450462Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX25RE2015-10-01
00699753450479Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX25RW2015-10-01
00699753450752Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RW402015-10-01
00699753450783Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RW30C2016-01-20
00699753450790Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RW40C2016-01-20
00699753450806Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RE30C2016-01-20
00699753450813Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX15RE40C2016-01-20
00699753450820Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX25REC2016-01-20
00699753450837Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.Terumo Cardiovascular Systems Corporation3CX*FX25RWC2016-01-20
00699753450868NX19 Oxygenator w/4-liter reservoir; right-side outlet portTerumo Cardiovascular Systems Corporation3CX*NX19RE 2021-03-18
00699753450875NX19 Oxygenator w/4-liter reservoir; left-side outlet portTerumo Cardiovascular Systems Corporation3CX*NX19RW 2021-03-18
00699753450882NX19 Oxygenator; right-side outlet portTerumo Cardiovascular Systems Corporation3CX*NX19E 2021-03-18
00699753450899NX19 Oxygenator; left-side outlet portTerumo Cardiovascular Systems Corporation3CX*NX19W2021-03-18
00699753450905NX19 East Sub-Assembly-Japan Only, Export OnlyTerumo Cardiovascular Systems CorporationCXOT2802021-03-19
00699753450912NX19 West Sub-Assembly-Japan Only, Export OnlyTerumo Cardiovascular Systems CorporationCXOT2812021-03-19
00699753450981NX19 Oxygenator; right-side outlet portTerumo Cardiovascular Systems Corporation3CX*NX19E 2021-03-18
00699753450998NX19 Oxygenator; left-side outlet portTerumo Cardiovascular Systems Corporation3CX*NX19W2021-03-18
00699753451001NX19 East Sub-Assembly-Japan Only, Export OnlyTerumo Cardiovascular Systems CorporationCXOT2802021-03-19
00699753451018NX19 West Sub-Assembly-Japan Only, Export OnlyTerumo Cardiovascular Systems CorporationCXOT2812021-03-19
00721902333880Affinity®MEDTRONIC, INC.CB5412015-06-16
00721902648755TRILLIUM™ AFFINITY®NTMEDTRONIC, INC.952492016-06-24
00721902648892TRILLIUM® AFFINITY NT®MEDTRONIC, INC.952502015-06-19
00721902673337TRILLIUM™ AFFINITY®MEDTRONIC, INC.952522015-06-18