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510(k) Data Aggregation

    K Number
    K102483
    Device Name
    SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
    Date Cleared
    2011-09-13

    (379 days)

    Product Code
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNSET HEALTHCARE SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross-contamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.
    Device Description
    The BHF 104 filter is a single-use, barrier type filter, fabricated from a plastic resin, and delivered to the customer in a sealed, non-sterile package. The translucent housing has aligned connector ports (15mm ID x 22mm OD, 22mm ID x 15mm OD), a perpendicular filter media, and a gas sampler luer port, protruding at 45 degrees from the base of the filter housing. The entire filter is 90mm (3.54 inches) in length, with a maximum cross section diameter of 55mm (2.16 inches), and a mass of 24g (.85 ounces). The surface area is 26.4cm2. The BHF 104 has 15mm ID x 22mm OD and 22mm ID x 15mm OD male and female connectors, which allows compatibility with various compressors, ventilators, masks, and aerosol tubes.
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