TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.


Product Overview

TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U
TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm) - 260312


Device Description

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Total Volume: 0.5 Milliliter
  • Length: 8 Millimeter
  • Needle Gauge: 31 Gauge
    • Total Volume: 0.5 Milliliter
    • Length: 8 Millimeter
    • Needle Gauge: 31 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FMF

    Device Name: Syringe, Piston

    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: 10015482263123

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00015482263126

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Master Shipper


    Device Id: 00015482263126

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00015482613129

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 00015482613129

    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: 50015482613124

    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


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