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510(k) Data Aggregation

    K Number
    K023595
    Device Name
    BURETTE-IN LINE (150 ML)
    Manufacturer
    TUTA HEALTHCARE PTY LIMITED
    Date Cleared
    2002-12-18

    (51 days)

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

    TUTA HEALTHCARE PTY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient's vascular system Through a cannula inserted into a vein.
    Device Description
    The Tuta Healthcare Burette - In Line (150 mL) is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient. The design of the Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set are similar in terms of components of , PVC tubing, roller regulators and perforators.
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    K Number
    K023039
    Device Name
    BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
    Manufacturer
    TUTA HEALTHCARE PTY LIMITED
    Date Cleared
    2002-11-07

    (56 days)

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

    TUTA HEALTHCARE PTY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein. Use of Needle-Free Access site may aide in the prevention of needlestick injury.
    Device Description
    The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.
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    K Number
    K020083
    Device Name
    TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
    Manufacturer
    TUTA HEALTHCARE PTY LIMITED
    Date Cleared
    2002-02-12

    (33 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TUTA HEALTHCARE PTY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).
    Device Description
    The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.
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