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510(k) Data Aggregation

    K Number
    K213183
    Device Name
    Safety Insulin Pen Needles
    Manufacturer
    Zhejiang Kindly Medical Devices Co. Ltd
    Date Cleared
    2022-10-14

    (380 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang Kindly Medical Devices Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.
    Device Description
    The proposed device, Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. It consists of needle tube, needle hub, spring, needle hub sheath, safety protective sheath, positioning ring, outer protective cap and sealing paper. The needle hub is clear, and the positioning ring and sealing paper contains colorants for the different gauge sizes. The Safety insulin needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
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    K Number
    K181069
    Device Name
    Disposable Insulin Pen Needle
    Manufacturer
    Zhejiang Kindly Medical Devices Co. Ltd
    Date Cleared
    2018-08-28

    (127 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang Kindly Medical Devices Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
    Device Description
    The proposed device, Disposable Insulin Pen Needle, is a single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of needle tube, inner sheath, cup, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The proposed device is available in following specifications: Gauge 33G, 32G, 31G, 30G, 29G, 28G and Length (mm) 4mm, 6mm, 8mm, 12mm.
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