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510(k) Data Aggregation

    K Number
    K250192

    Validate with FDA (Live)

    Date Cleared
    2025-12-10

    (321 days)

    Product Code
    Regulation Number
    880.5860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Verisafe Safety Ret retractable Insulin Syringes are intended for aspiration and subcutaneous injection of insulin. After injection, the needle can be retracted directly from the patient's skin into the syringe barrel to avoid exposure to a contaminated needle, thereby minimizing accidental needle stick injuries.

    Device Description

    Safety Retractable Insulin Syringes is a sterile device consisting of a calibrated barrel, plunger, piston, push button, retraction cylinder, sealing ring, spring and a needle. It is made of plastic, stainless steel and silicone materials. Type 5 is a syringe with a fixed needle.

    The needle cap color is used to indicate insulin concentration that red for U40 and orange for U100.

    Safety Retractable Insulin Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury.

    Product is delivered sterile. Sterilization process is validated according to EN ISO 11135.

    This is a single-use device. Safety Sterile Syringes is intended to be used in Professional Healthcare Facility,
    Home Environment and Transport (Ambulatory) Environment.

    AI/ML Overview

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