On-Body Infusor and Prefilled Cartridge


Product Overview

On
Repatha Pushtronex System - 9006655


Device Description

A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep out of the sight and reach of children
  • Special Storage Condition, Specify
    • Keep Dry
  • Special Storage Condition, Specify
    • Store in Carton to Protect from Light
  • Special Storage Condition, Specify
    • Do Not Freeze or Shake
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 15.00
  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • Total Volume: 3.5 Milliliter
    • Total Volume: 3.5 Milliliter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FRN

    Device Name: Pump, Infusion

    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: 880.5725

    Third Party Flag: N

    Medical Specialty: HO


    Device Identifiers

    Device Id: 10372511770015

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00372511770018

    Package Quantity: 20

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 00372511770018

    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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