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510(k) Data Aggregation

    K Number
    K233794
    Device Name
    Insulin Syringe
    Manufacturer
    SPM Medicare Pvt. Ltd.
    Date Cleared
    2024-03-06

    (99 days)

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

    SPM Medicare Pvt. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.
    Device Description
    The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made of polypropylene.
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    K Number
    K231724
    Device Name
    Flush Syringe (Prefilled 0.9% normal saline solution)
    Manufacturer
    SPM Medicare Pvt. Ltd.
    Date Cleared
    2023-11-09

    (149 days)

    Product Code
    NGT, REG
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPM Medicare Pvt. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
    Device Description
    Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
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