FDA.reportPublic FDA data

Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir

Primary DI
00699753450141
Brand
Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir
Company
Terumo Cardiovascular Systems Corporation
Model
3CX*RX15RW40
Published
2015-10-01
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
DTNReservoir, Blood, Cardiopulmonary Bypass
DTPDefoamer, Cardiopulmonary Bypass
DTRHeat-Exchanger, Cardiopulmonary Bypass
DTZOxygenator, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTPDefoamer, Cardiopulmonary BypassCardiovascular2
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450146PackageGS14In Commercial Distribution
00699753450141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345014650699753450146
00699753450141006997534501416997534501410699753450141

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
00699753532731Cardiovascular Procedure Kit75959-022024-08-23
00699753532663Cardiovascular Procedure Kit73346-022024-08-20
00699753532250Cardiovascular Procedure Kit75197-012024-07-19
00699753531666Cardiovascular Procedure Kit74100-032024-06-04
00699753531345Cardiovascular Procedure Kit77087-012024-05-09
00699753531017Cardiovascular Procedure Kit65167-072024-03-21
00699753537439Cardiovascular Procedure KitCX-SV1272026-05-15
00699753537446Cardiovascular Procedure KitCX-SV1292026-05-15
00699753537453Cardiovascular Procedure Kit787752026-05-15
00812763011007OPUSWAVE01000-002026-05-13
00699753537378Cardiovascular Procedure KitCX-CZ2172026-05-05
00699753537361Cardiovascular Procedure KitCX-GE468X2026-05-04
00699753537385Cardiovascular Procedure KitCX-IS1272026-05-04
00699753537392Cardiovascular Procedure KitCX-SV1262026-05-04
00699753537408Cardiovascular Procedure KitCX-SV1282026-05-04
00699753537415Cardiovascular Procedure Kit780832026-05-04
00699753537422Cardiovascular Procedure Kit786492026-05-04
00699753532601Cardiovascular Procedure Kit74121-032024-08-08
00699753531406Cardiovascular Procedure Kit75472-012024-05-10
00699753531420Cardiovascular Procedure Kit75140-012024-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 SRLDTZ2026-05-05
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
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
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLDTN2024-12-20