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510(k) Data Aggregation

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    Reference Devices :

    K220204

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.

    Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body.

    Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

    Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.

    Device Description

    Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe consists of a barrel with a Luer Slip or Luer Lock connector which comply with ISO 80369-7, a plunger, and a plunger stopper. The device is available in 0.5 mL and 1 mL capacities. It is sterile, single-use, and non-toxic device that operates on the principle of a piston syringe.

    Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle: Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is sterile, single-use device. Each consists of either a Luer slip or Luer lock syringe assembly integrated with a pre-attached needle, and the syringe is available in two capacities (0.5mL and 1mL). For each capacity variant, the pre-attached needle is available in the following gauge specifications: 16G, 18G, 19G, 21G, 22G, 23G, 25G, 27G and 30G.

    Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle: Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.

    Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe: Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.

    AI/ML Overview

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