Product Overview

Medex - MX491B


Device Description

A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

  • Radiation Sterilization
    • Radiation Sterilization


    Product Codes

    Code: FPA

    Device Name: Set, Administration, Intravascular

    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: 880.5440

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 50351688506939

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10351688506931

    Package Quantity: 100

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10351688506931

    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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