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510(k) Data Aggregation

    K Number
    K093426
    Device Name
    BACT-TRAP HEPA MIDI
    Manufacturer
    Date Cleared
    2010-02-22

    (111 days)

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

    PHARMA SYSTEMS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml. May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.
    Device Description
    The Bact-Trap™ HEPA Midi filter incorporates standard 15 / 22 mm connectors with a gas sampling luer port. It utilizes an electrostatic media for the filtration function. The "HEPA" performance was tested in accordance to DOE 3020-97 and ASTM D2986 - 95a DOP at 30 Ipm. The filter functions by electrostatic capture.
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