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510(k) Data Aggregation

    K Number
    K090459
    Device Name
    DISPOSABLE TPE INFUSION SET
    Manufacturer
    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
    Date Cleared
    2009-10-13

    (232 days)

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

    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable TPE 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 is 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 thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; 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; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel. The proposed device is provided sterilized.
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    K Number
    K090012
    Device Name
    DISPOSABLE INFUSION SET
    Manufacturer
    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
    Date Cleared
    2009-06-11

    (160 days)

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

    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 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, there is no DEHP used in the proposed device; 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; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel. The proposed device is provided sterilized.
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    K Number
    K083349
    Device Name
    BLOOD TRANSFUSION SET
    Manufacturer
    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
    Date Cleared
    2009-04-10

    (148 days)

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

    SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.
    Device Description
    The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method. The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't. There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle. The proposed device is provided sterilized.
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