CARDINAL HEALTH


Product Overview

CARDINAL HEALTH - ED3231-CM


Device Description

A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.


Environmental Conditions

No Data Available


Device Sizes

  • 23G x 1" (0.6mm x 25mm)
    • 23G x 1" (0.6mm x 25mm)


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MEG

    Device Name: Syringe, Antistick

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    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: 880.5860

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 35019517065903

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 15019517065909

    Package Quantity: 50

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: BOX


    Device Id: 15019517065909

    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: 55019517065907

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 35019517065903

    Package Quantity: 8

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


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