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510(k) Data Aggregation

    K Number
    K162562
    Device Name
    OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
    Manufacturer
    Date Cleared
    2017-03-17

    (184 days)

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

    BCG MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Opt-Shield AIR Convection Warming technology is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patient to become too cold.
    Device Description
    Proposed device: Opt-Shield™ AIR. SAFE Patient-Handling System for Surgical Patient: The proposed Opt-Shield AIR blanket consists of three layers of material: bottom layer nylon impermeable to air (non-contact), middle layer plastic with predetermined holes (non-contact), and top layer polypropylene (in contact with the patient) with microscopic holes (intrinsic to the fabric) throughout the fabric. The three layers are sewn together to create air channels to allow air distribution evenly throughout the blanket to minimize heat reduction. The warm air circulates within blanket and delivers warm air around the patient's body through perforations in the patient side layer of the blanket. The distribution of air is designed to equally deliver air at the similar temperature air at various blanket locations. It has one hose port for receiving warm air.
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