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510(k) Data Aggregation

    K Number
    K131646
    Device Name
    DISPOSABLE INFUSION SET
    Date Cleared
    2013-11-26

    (174 days)

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

    SHANGHAI JINTA MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JT series Disposable infusion set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
    Device Description
    The applicant device-JT series disposable infusion set is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Male conical fitting is used for connecting with vein needle for medical solution transfusion. The proposed device is provided sterilized.
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