Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.


Product Overview

Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
TechLITE PEN NEEDLES - 236131


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

No Data Available


Device Sizes

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge
    • Length: 6 Millimeter
    • Needle Gauge: 31 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FMI

    Device Name: Needle, Hypodermic, Single Lumen

    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: 880.5570

    Third Party Flag: Y

    Medical Specialty: HO


    Device Identifiers

    Device Id: 10015482236318

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00015482236311

    Package Quantity: 30

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case Pack


    Device Id: 00015482236311

    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: 50015482236316

    Device Type: Unit of Use

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos