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510(k) Data Aggregation

    K Number
    K120412
    Device Name
    3M SPOTON TEMPERATURE MONITORING SYSTEM
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2012-05-30

    (110 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARIZANT HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measure, monitor, and trend body temperature of adult and pediatric patients.
    Device Description
    The 3M™ SpotOn™ temperature monitoring system consists of a disposable sensor, a control unit, a power supply cord, and an optional interface cable that allows temperature data to be transmitted to a standard YSI-400 input on a vital signs monitor.
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    K Number
    K082217
    Device Name
    RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2008-10-06

    (61 days)

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

    ARIZANT HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ranger Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.
    Device Description
    The Ranger Rapid Flow blood/fluid warming system is a stand-alone system that warms fluid, detects fluid level within the bubble trap, controls a patient valve, and delivers high volumes of fluid under pressure. The warming system consists of warming plates, fluid detection, valve control, pressure infusors and a fluid warming disposable set.
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    K Number
    K060939
    Device Name
    RANGER IRRIGATION FLUID WARMING SYSTEM
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2006-06-26

    (81 days)

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

    ARIZANT HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.
    Device Description
    The Ranger Irrigation Fluid Warming System consists of a warming device and an irrigation fluid warming disposable set. The warming device consists of the electronic control circuitry and aluminum plates contacted by heating elements. The irrigation disposable sets are an integral component of the total fluid warming system. One standard irrigation fluid warming disposable set is available. The irrigation sets include a warming cassette (heat exchanger), tubing, connectors, flow chamber with float, and clamps. The warming cassette fits inside a slot in the warming device; liquids are warmed as they pass through it.
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    K Number
    K060865
    Device Name
    BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2006-04-24

    (25 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARIZANT HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
    Device Description
    The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
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    K Number
    K053645
    Device Name
    MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2006-03-09

    (69 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARIZANT HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
    Device Description
    The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
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    K Number
    K041686
    Device Name
    BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Date Cleared
    2004-06-30

    (8 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARIZANT HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.
    Device Description
    The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).
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