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510(k) Data Aggregation

    K Number
    K152208
    Device Name
    The Belmont Hyperthermia Pump
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Date Cleared
    2015-09-02

    (26 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BELMONT INSTRUMENT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Belmont® Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.
    Device Description
    The Belmont® Hyperthermia Pump combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid perfusion of warmed fluid. It can raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician. The system monitors fluid temperature, patient temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid pumped, output fluid temperature, target temperature, patient temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.
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    K Number
    K141654
    Device Name
    THE BELMONT RAPID INFUSER
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Date Cleared
    2014-07-18

    (28 days)

    Product Code
    FRN, LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BELMONT INSTRUMENT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. - Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. - Infusion of warmed fluid for irrigation in urology procedures.
    Device Description
    The Belmont® Rapid Infuser, RI2, (same as the existing Rapid Infuser) combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. . The Rapid Infuser infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 milliliters per minute (ml/min). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.
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