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510(k) Data Aggregation

    K Number
    K112488
    Device Name
    HOTDOG PATIENT WARMING SYSTEM
    Manufacturer
    AUGUSTINE BIOMEDICAL & DESIGN, LLC
    Date Cleared
    2011-11-23

    (86 days)

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

    **AUGUSTINE BIOMEDICAL **& DESIGN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDoq Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The patient warming system can be used with adult and pediatric patients. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical - floors.
    Device Description
    The HotDog Patient Warming System consists of a temperature control unit that monitors and controls the temperature of a patient warming blanket or mattress. The blankets and mattresses are composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
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    K Number
    K094056
    Device Name
    HOTDOG MULTI FUNCTION CONTROLLER
    Manufacturer
    AUGUSTINE BIOMEDICAL & DESIGN, LLC
    Date Cleared
    2010-06-03

    (154 days)

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

    **AUGUSTINE BIOMEDICAL **& DESIGN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
    Device Description
    The Hot Dog Multifunction Controller consists of a temperature control unit that monitors and controls the temperature of patient warming blankets and mattresses.
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    K Number
    K092807
    Device Name
    HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
    Manufacturer
    AUGUSTINE BIOMEDICAL & DESIGN, LLC
    Date Cleared
    2009-12-10

    (90 days)

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

    **AUGUSTINE BIOMEDICAL **& DESIGN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hot Dog Patient Warming Mattress System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
    Device Description
    The Hot Dog Patient Warming Mattress System consists of a temperature control unit that monitors and controls the temperature of a patient warming mattress. The mattress is composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
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    K Number
    K052392
    Device Name
    HOT DOG PATIENT WARMING SYSTEM
    Manufacturer
    AUGUSTINE BIOMEDICAL & DESIGN, LLC
    Date Cleared
    2006-05-04

    (246 days)

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

    **AUGUSTINE BIOMEDICAL **& DESIGN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming System should be used in circumstances in which patients could become cold. The system in intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms, burn units and on medical/surgical floors.
    Device Description
    The Hot Dog Patient Warming System is designed to compensate for body heat loss before, during and after surgery and in other situations in which a patient could become cold. The device consists of four primary components, the outer Warming Blanket (disposable), the Warming Pad, Connecting, Cable and the Temperature Controller. The outer Warming Blanket is placed atop the patient, and the Warming Pad is placed over the outer Warming Blanket. The microprocessor based Temperature Controller uses 110-240 VAC line voltage and is connected to the Warming Pad via a cable. The Controller output to the Warming Pad is 48 VDC or less.
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