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510(k) Data Aggregation

    K Number
    K151040
    Device Name
    Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
    Manufacturer
    BIOMETRIX LTD.
    Date Cleared
    2015-09-04

    (137 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMETRIX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients. The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder. The device is for single and short term use.
    Device Description
    The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.
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    K Number
    K011216
    Device Name
    PVC FREE INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    BIOMETRIX LTD.
    Date Cleared
    2001-07-18

    (89 days)

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

    BIOMETRIX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001461
    Device Name
    TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
    Manufacturer
    BIOMETRIX LTD.
    Date Cleared
    2000-09-11

    (124 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMETRIX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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