FDA.reportPublic FDA data

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

Primary DI
50699753450801
Brand
Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.
Company
Terumo Cardiovascular Systems Corporation
Model
3CX*FX15RE30C
Published
2016-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTRHeat-Exchanger, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151389000Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell ReservoirTerumo Cardiovascular Systems Corporation2015-10-20DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450801PackageGS14In Commercial Distribution
00699753450806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345080150699753450801
00699753450806006997534508066997534508060699753450806

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753525054Cardiovascular Procedure KitCX-RU0642022-12-13
00699753537460Cardiovascular Procedure KitCX-DB080-012026-06-02
00699753537477Cardiovascular Procedure Kit787792026-06-02
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

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Primary DI, Brand, Company table
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18051160302236Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
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08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
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18051160302205Quantum PureFlow Standard Heat Exchanger High Flow 3/8 WSPECTRUM MEDICAL SRLDTR2024-11-19
18051160302267Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 WSPECTRUM MEDICAL SRLDTR2024-11-19
05060491619810CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2024-10-07
04987350743251CAPIOXTERUMO CORPORATIONDTR2024-05-20
54987350743256CAPIOXTERUMO CORPORATIONDTR2024-05-20
08033178112840KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
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38033178113466KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
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20634624530397MPS 3 Drug Pump CoverQUEST MEDICAL INCDTR2023-03-24
08051160301003Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8SPECTRUM MEDICAL SRLDTR2022-05-30
08051160301171Quantum PureFlow Standard Heat Exchanger High Flow 3/8SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301188Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301195Quantum PureFlow Standard Heat Exchanger Low Flow 3/16SPECTRUM MEDICAL SRLDTR2022-02-16