RESERVOIR 61399409462 AFFINITY 540 4PK


Product Overview

RESERVOIR 61399409462 AFFINITY 540 4PK
AFFINITY® NT - 61399409462


Device Description

A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • N/A

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DTN

    Device Name: Reservoir, Blood, 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: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.4400

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 20613994375661

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00613994375667

    Package Quantity: 4

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PK


    Device Id: 00613994375667

    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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