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510(k) Data Aggregation

    K Number
    K112204
    Device Name
    KDL DISPOSABLE INFUSION SET
    Manufacturer
    SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.
    Date Cleared
    2012-09-10

    (406 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KDL Disposable Infusion Set is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
    Device Description
    The proposed device, KDL Disposable Infusion Set, is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The proposed device consists of protective cap, air filtration membrane, air-inlet set, closure-piercing device, drip chamber, medicine fluid filter, locked clamp, tubing, check valve, flow regulator, clamp, injection sites, two-part luer lock connector, infusion needle. The protective cap is intended to protect the needle; the closure-piercing device is used to pierce the container; the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution; the locked clamp is used to control the flow of the medicine solution; the tubing is used to connect various components; the check valve is used to make the medicine solution flow in one direction; the flow regulator is used to adjust the flow rate from zero to maximum; there are two injection sites, one is needleless and the other is needle access, which are used to inject solution into the tubing; two-part luer lock connector is used to connect the infusion needle with the tubing; infusion needle is inserted into human vessel for medical solution transfusion and it is made of stainless steel. It is provided EO sterilized.
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