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510(k) Data Aggregation

    K Number
    K132110
    Device Name
    NATUS WARMETTE BLANKET AND DUAL CABINETS
    Date Cleared
    2013-10-03

    (86 days)

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

    NATUS NICOLET IRELAND LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (Irrigation and/or Injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.
    Device Description
    The Natus Warmette® Cabinets are made of stainless steel and are well insulated to reduce heat loss and noise. Cabinet doors are double glazed with safety glass. A pull out shelf inside the top of the cabinet contains the heating element, fan, thermostat and temperature sensor. The electronics are located on the outside top of the cabinet and the power cable is connected at the back of the electronic cabinet. Wheeled shelves and baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning or repositioning. The Natus Warmette® Blanket Cabinet is factory-set to 130ºF (54ºC) with a temperature range of 95º - 176ºF (35º -80°C). For the Natus Warmette® Dual Cabinet, the blanket and linen compartment is factory-set to 130°F (54°C) with a temperature range of 95° - 1769F (35° - 80°C); while the fluid compartment is factory-set to 110°F (43°C) with a temperature range of 970 - 122°F (36° - 50°C). The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment, and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items. The cabinet and its contents are warmed by circulating warm air which is heated by a warming element. The hot air is circulated by a fan and distributed evenly through the outlets. The temperature is regulated by the temperature regulator T1 to the set temperature. Thermostat T2 functions as over temperature protection and will take over the temperature control in case the air temperature exceeds set maximum temperature by 90F (5°C). At the same time the red lamp on the front panel will be lit to indicate that there is a malfunction. Inside the heating element itself, there is an additional over temperature protection that is self-resetting. It will be activated in case the fan stops or goes too slow.
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