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510(k) Data Aggregation

    K Number
    K080117
    Device Name
    PATIENT ISOLATION UNIT, MODEL G019-1000
    Manufacturer
    GENTEX CORPORATION
    Date Cleared
    2009-01-30

    (379 days)

    Product Code
    LGM
    Regulation Number
    880.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENTEX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment. The PIU is intended to be used as a means to temporarily isolate a contaminated patient , outside or within patient care facilities. The PIU can also be used to transport those patients within vehicles, including aircraft, via a NATO-type or similar litter/gumey.
    Device Description
    The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment.
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