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510(k) Data Aggregation

    K Number
    K112840
    Device Name
    CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
    Manufacturer
    Date Cleared
    2012-07-13

    (288 days)

    Product Code
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEEBREATH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CapnoDura Pedi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 1 kg - 15 kg. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes. CapnoDura Combi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 10 kg or above. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
    Device Description
    The CapnoDura Combi & CapnoDura Pedi CO2 Detectors are non-sterile, single use, colorimetric CO2 detectors to be connected between a breathing circuit and a tracheal tube. The colorimetric indicator area in the center of the device indicates the presence of carbon dioxide during the breathing to assist verification of tracheal tube placement in trachea following intubation and to observe respiration by the detector's color changes The indicator panel is blue when no CO2 is present, green at intermediate concentrations and yellow when approximately 5% CO2 is present. A permanent blue or blue-green color indicates absence of exhaled CO2. A damaged indicator will exhibit a permanent yellow or white color. The unit has a printed reference scale against which the actual indicator color may be compared to obtain an approximate CO2 concentration. There are two sizes of the detector, Combi and Pedi, and these will fit with the breathing circuit and tracheal tube connections for both adults and children, respectively. The connections are ISO standard dimensions
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