PK CB4J02R1 SET A


Product Overview

PK CB4J02R1 SET A
NA - CB4J02R1


Device Description

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • 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: 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: 20885074489784

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00885074489780

    Package Quantity: 5

    Package Discontinue Date: 10/24/2018 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: PK


    Device Id: 00885074489780

    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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