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510(k) Data Aggregation

    K Number
    K211286
    Device Name
    Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
    Manufacturer
    Pall Corporation
    Date Cleared
    2021-11-16

    (203 days)

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

    Pall Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pal® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moisture exchanger (HME) for patient side or machine side installation in breathing systems. It is designed to reduce bacterial/viral transmissions between the patient, the equipment and the environment and to reduce the loss of patient heat and humidity. The Ultipor® U55/U55N breathing circuit filter has >99.999% bacterial and >99.995% viral efficiency. The filter is for single patient use for adult patients, and is intended for use within breathing systems in healthcare and home environments where ventilation is required and for a maximum duration of 24 hours.
    Device Description
    The Pall® Ultipor®U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger is a disposable, highly efficient, bi-directional bacterial/viral filter for patient ventilation solutions and is comprised of the following components: - . Filter housing - Is comprised of two molded halves, an inlet housing and an outlet housing that are joined and sealed together. The finished filter housing holds the pleated hydrophobic filter media and provides conical (tapered) fittings on opposing sides of the finished housing to provide connection to the conventional equipment used in the breathing circuit. One side of the finished housing has a coaxial conical fitting, with a conical fitting located on the opposing side. - Hydrophobic filter media Provides airborne bacterial removal efficiency of >99.999%, . airborne viral removal efficiency of >99.995% and waterborne microbial contaminant removal efficiency of 100%. If the filter is used at the patient end, the filter media also acts as a heat and moisture exchanger (HME) by conserving a proportion of the heat and humidity present in the patient's exhaled air and returning it to the patient on the next inspiration.
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