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    K Number
    K011907
    Device Name
    SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
    Manufacturer
    SIMS LEVEL 1, INC.
    Date Cleared
    2001-12-18

    (183 days)

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

    SIMS LEVEL 1, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
    Device Description
    The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
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    K Number
    K001764
    Device Name
    HOTLINE 2 FLUID WARMER
    Manufacturer
    SIMS LEVEL 1, INC.
    Date Cleared
    2000-08-09

    (58 days)

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

    SIMS LEVEL 1, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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