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510(k) Data Aggregation

    K Number
    K050381
    Device Name
    CS MEDICAL TTCF GAS DELIVERY SYSTEM
    Manufacturer
    CS MEDICAL INC.
    Date Cleared
    2005-07-13

    (148 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    CS MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.
    Device Description
    The TTCF Gas Delivery System is a gas supply and humidification system mounted on a medical stand. Components include an oxygen blender, a flow meter, pressure relief valve, humidifier, and pressure monitor. A blended source of compressed air and oxygen allow choosing flow rate and FiO2 of the mixture. Flows are delivered at 6-15 LPM. Oxygen concentrations are available from 21% to 77%.
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    K Number
    K050379
    Device Name
    CS MEDICAL ADULT TTCF CATHETER
    Manufacturer
    CS MEDICAL INC.
    Date Cleared
    2005-07-12

    (147 days)

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

    CS MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.
    Device Description
    The TTCF Catheter is constructed of clear, latex-free plastics with a radiopaque stripe for identification by x-ray. A rounded tip facilitates insertion and minimizes potential mucous irritation or injury. The catheter is 4 mm O.D. used within an adult Portex Blue Line Fenestrated Tracheostomy Tube. Inner diameter is 3.1 mm in 11.5, 13.5 and 15.5 cm lengths. The distal end is an 11 mm connector capable of attaching to the CS Medical Mid-section Hose. The catheter is supplied sterile and designed as single patient use.
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