1 mL TB 25 Ga. x 5/8 in. Detachable Needle


Product Overview

1 mL TB 25 Ga. x 5/8 in. Detachable Needle
Omnifix™ - 9161422-02


Device Description

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Total Volume: 1.0 Milliliter
  • Gauge (cannula) : 25
    • Total Volume: 1.0 Milliliter
    • Gauge (cannula) : 25


    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


    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: 04046963452414

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04046963452407

    Package Quantity: 16

    Package Discontinue Date: 4/4/2020 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Carton


    Device Id: 04046963452407

    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: 04046964354373

    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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