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510(k) Data Aggregation

    K Number
    K250138
    Device Name
    Small Volume 0.2mL Syringe
    Manufacturer
    Prosum Medical Limited
    Date Cleared
    2025-04-02

    (75 days)

    Product Code
    QNQ
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prosum Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Small Volume 0.2mL Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
    Device Description
    The Small Volume 0.2mL Syringe is intended for manual, single use. It is a small volume 0.2 mL syringe. It is comprised of a PP barrel, ABS plunger, TPE plunger stopper, PP plunger shield and PP Luer protective cap. The device has a Luer lock connection type that enables connection to a hypodermic needle for liquid injection or withdrawal. The device has a plunger stopper to prevent any liquid residual from remaining in the syringe barrel, maximizing the efficiency of liquid usage. The feature is called Low Dead Space/Volume. The Luer protective cap serves to safeguard the small Luer connector from potential damage during transportation. Similarly, the plunger shield is utilized to ensure the small plunger remains undamaged during transportation. The Luer protective cap and the plunger shield are optional to be used. The device has been manufactured without any silicone oil. The device has six models, each equipped with a 0.2 mL Luer lock syringe. Among these models, three include an additional feature for enhanced dosing technology (EDT), which comprises a colored reference line on the plunger surface to improve visibility. These include identifying markings to distinguish the EDT models from the regular 0.2 mL syringe.
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