Product Overview

FX05
CAPIOX®FX - CX*FX05RW


Device Description

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.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • 1.00
  • Special Storage Condition, Specify
    • Fragile. This way up. Keep away from sunlight. Keep away from rain.

  • Device Sizes

  • Area/Surface Area: 0.5 Square meter
    • Area/Surface Area: 0.5 Square meter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DTZ

    Device Name: Oxygenator, Cardiopulmonary Bypass

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.4350

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 04987350781772

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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