FDA.reportPublic FDA data

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

Primary DI
00699753450837
Brand
Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.
Company
Terumo Cardiovascular Systems Corporation
Model
3CX*FX25RWC
Published
2016-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
DTNReservoir, Blood, Cardiopulmonary Bypass
DTRHeat-Exchanger, Cardiopulmonary Bypass
DTZOxygenator, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial LineCardiovascular2
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450832PackageGS14In Commercial Distribution
00699753450837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345083250699753450832
00699753450837006997534508376997534508370699753450837

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA 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.

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753532069Cardiovascular Procedure Kit75411-042024-07-09
00699753532021Cardiovascular Procedure Kit74454-052024-07-08
00699753531932Cardiovascular Procedure Kit78044-012024-07-02
00699753531567Cardiovascular Procedure Kit72149-022024-05-29
00699753531574Cardiovascular Procedure Kit77742-012024-05-29
00699753517721Cardiovascular Procedure Kit75410-022022-10-19
00699753538177Cardiovascular Procedure Kit76754-012026-10-22
00699753538184Cardiovascular Procedure Kit788202026-10-22
00699753538191Cardiovascular Procedure KitCX-UK7722026-10-22
00699753538061Cardiovascular Procedure KitCX-CZ227X2026-10-09
00699753538078Cardiovascular Procedure KitCX-CZ2282026-10-09
00699753538085Cardiovascular Procedure KitCX-SP296X2026-10-09
00699753538092Cardiovascular Procedure KitCX-SP297X2026-10-09
00699753538108Cardiovascular Procedure Kit787582026-10-09
00699753538115Cardiovascular Procedure Kit788232026-10-09
00699753538122Cardiovascular Procedure Kit787472026-10-09
00699753538139Cardiovascular Procedure Kit787482026-10-09
00699753538146Cardiovascular Procedure Kit787442026-10-09
00699753538153Cardiovascular Procedure Kit787462026-10-09
00699753538160Cardiovascular Procedure Kit787452026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622164910Perfusion PackLIVANOVA USA, INC.DTN2026-10-19
08054117378264HORIZON 8AFEUROSETS SRLDTR2026-10-15
08054117378264HORIZON 8AFEUROSETS SRLDTN2026-10-15
08054117378264HORIZON 8AFEUROSETS SRLDTM2026-10-15
08054117378264HORIZON 8AFEUROSETS SRLDTZ2026-10-15
00803622164859Perfusion PackLIVANOVA USA, INC.DTN2026-09-29
00803622164378Perfusion PackLIVANOVA USA, INC.DTN2026-09-22
00634624530485MPS® 3 Console Pole Mount PlateQUEST MEDICAL INCDTR2026-07-20
06974762681019LifemotionLifemotion Medical Technology Co., Ltd.DTZ2026-06-02
18051160300676Quantum Perfusion Blood Oxygenator VT200-E1SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300706Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
08054117372446TRILLYEUROSETS SRLDTM2026-05-05
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTM2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160303363Quantum Perfusion Blood Oxygenator VT75-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178112857KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178112871KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31