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510(k) Data Aggregation

    K Number
    K180842
    Device Name
    MAC Medical D-Series Blanket and Solution Warming Cabinets
    Manufacturer
    MAC Medical Inc.
    Date Cleared
    2019-03-05

    (340 days)

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

    MAC Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/ or injection fluids in accordance with the recommended warming temperatures and storage guidelines provided by the manufacturers of such products.
    Device Description
    The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/ or blankets to an acceptable level for hospital and surgical outpatient center applications. The MAC Medical D-Series Warming Cabinets are constructed with stainless steel panels, headers and doors. The Warming Cabinets are doubled walled constructed and are fully insulated to provide uniform heating. Optional glass doors are double paned tempered glass with aluminum. 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 of the cabinet and the power cable is connected in the back of the cabinet. The wheeled baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning and repositioning.
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