Assembly, Packaged Pump, t:flex


Product Overview

Assembly, Packaged Pump, t:flex
t:flex Insulin Pump - 005365


Device Description

An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 20.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -4.00

  • Device Sizes

  • Total Volume: 4.8 Milliliter
    • Total Volume: 4.8 Milliliter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LZG

    Device Name: Pump, Infusion, Insulin

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CH

    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: 00852162004385

    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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