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510(k) Data Aggregation

    K Number
    K120079
    Device Name
    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
    Manufacturer
    PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
    Date Cleared
    2012-05-24

    (135 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMED HALBERSTADT MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
    Device Description
    The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient. The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.
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