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510(k) Data Aggregation

    K Number
    K071269
    Device Name
    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2007-08-01

    (86 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Why did this record match?
    Product Code :

    CBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
    Device Description
    Not Found
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    K Number
    K070340
    Device Name
    SECURE ARTERIAL BLOOD SAMPLING SYSTEM
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2007-03-15

    (37 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Why did this record match?
    Product Code :

    CBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
    Device Description
    The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.
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    K Number
    K955663
    Device Name
    ABC IN-LINE BLOOD SAMPLING KIT
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-03-17

    (460 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Why did this record match?
    Product Code :

    CBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.
    Device Description
    The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.
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