CAPIOX®ARTERIAL FILTER


Product Overview

CAPIOX®ARTERIAL FILTER - CX*AF02


Device Description

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). 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

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DTM

    Device Name: Filter, Blood, Cardiopulmonary Bypass, Arterial Line

    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: 870.4260

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 54987350705636

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350705631

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 04987350705631

    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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