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510(k) Data Aggregation

    K Number
    K960916
    Device Name
    SAMS 8000 CARDIOPLEGIA MONITOR
    Manufacturer
    3M HEALTH CARE, SARNS
    Date Cleared
    1996-06-04

    (90 days)

    Product Code
    DSJ, DSK, DWB
    Regulation Number
    870.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M HEALTH CARE, SARNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardiopleqia doses, and tracks the volume of cardioplegia delivered.
    Device Description
    The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The Sarns 8000 Cardioplegia Monitor can display two pressures and three temperatures from attached probes. The pressure has alert and alarm levels which are set by the operator. The Sarns 8000 Cardioplegia Monitor also has a timer for use in tracking the time during and between doses of cardioplegia. With the new added features, it also displays the volume of cardioplegia delivered to the patient. The Sarns 8000 Cardioplegia Monitor communicates with the Sarns 8000 Roller Pump for obtaining volume information and to stop the roller pump (designated for cardioplegia delivery) during a pressure alarm condition if set by the operator to do so. The Sarns 8000 Cardioplegia Monitor also communicates with the Sarns 8000 Data Communications Module for purposes of data acquisition.
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    K Number
    K953901
    Device Name
    SARNS 800 ROLLER PUMP
    Manufacturer
    3M HEALTH CARE, SARNS
    Date Cleared
    1996-04-19

    (245 days)

    Product Code
    DWB
    Regulation Number
    870.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M HEALTH CARE, SARNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sarns 8000 Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
    Device Description
    The Sarns 8000 Roller Pump consists of a Universal Roller Pump, which is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion, and a power supply. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 8000 Roller Pump can be used as a stand-alone device or it is compatible with the Sarns 8000 Modular Perfusion System.
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