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510(k) Data Aggregation

    K Number
    K052798
    Device Name
    CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
    Date Cleared
    2006-06-06

    (246 days)

    Product Code
    Regulation Number
    880.5450
    Why did this record match?
    Product Code :

    LGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAPSULS™ (Containment and Protection System Utilizing Life Support) is a portable Patient Isolation Unit (PIU), which prevents particulate (biological and radiological) cross-contamination between the patient and the external environment; and with features that enable medical intervention to the patient via end-user supplied medical equipment. The CAPSULS is intended to be used for: - . The transport and isolation of patients on aircraft, ambulances, ships, and any vehicle capable of safely transporting a patient on a standard litter, - . The temporary isolation, with or without transport, of patients within hospitals or other medical facilities.
    Device Description
    The CAPSULS (Containment And Protection System Utilizing Life Support) Patient Isolation Unit Model 2004 is a clear, tubular, flexible, patient isolation unit (PIU) for use during transport and evacuation. Each unit employs a clear envelope (either polyurethane [PUR] or polyvinylchloride [PVC]) to allow visual monitoring of the patient; the unit also has multiple glove arms and tubular access ports to facilitate medical intervention. The PIUs have a reinforced base mat with integrated handholds and tethers to enable lifting and attachment to a standard litter, and are supported by external ribs and end stanchions. Chamber airflow to the patient is provided by a battery-powered airpurifying respirator, which HEPA-filters contaminated air. The unit is operated under negative pressure mode during transport of a contaminated patient, and is operated in positive pressure mode during transport of a patient through a contaminated environment.
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