CAPIOX® SP PUMP


Product Overview

CAPIOX® SP PUMP
CAPIOX® SP PUMP - CX*SP45


Device Description

A mains electricity (AC-powered), specially constructed, centrifugal pump that is used to maintain blood circulation in heart failure. It is used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function. This dependence will be due to the lack of the heart's ability to function normally. The pump may be used during open heart surgery and postoperatively for a short period to assist the heart in regaining function.


Environmental Conditions

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

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KFM

    Device Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

    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: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.4360

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 04987350706119

    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


    Device Id: 54987350706114

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350706119

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: 10 Piece Case


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