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510(k) Data Aggregation

    K Number
    K190022
    Device Name
    SafeBreath Filter Mouthpiece
    Manufacturer
    MD Diagnostics Limited
    Date Cleared
    2019-09-25

    (264 days)

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

    MD Diagnostics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To filter possible bacteria and viruses from the patient exhalation, for use with carbon monoxide monitors. For use by healthcare professionals only.
    Device Description
    The SafeBreath Filter mouthpiece is a single patient contacting mouthpiece consisting of a 22mm diameter cardboard tube with a filter for the filtration of possible bacteria and viruses from the patient exhaled breath into the breath monitor device to prevent cross contamination. The SafeBreath mouthpieces connect directly to the carbon monoxide monitors, such as CO Check Pro and CO Screen (K171129).
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    K Number
    K171129
    Device Name
    CO Check Pro, CO Screen
    Manufacturer
    MD Diagnostics Limited
    Date Cleared
    2018-03-02

    (319 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Applicant Name (Manufacturer) :

    MD Diagnostics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For monitoring of carbon monoxide in adult exhaled breath. They are in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. Also can be used for ambient air monitoring. For use by healthcare professionals only in professional healthcare facilities.
    Device Description
    The Carbon monoxide monitors (CO Check Pro & CO Screen) are hand held, battery powered, carbon monoxide analyzers, used for monitoring the concentration of carbon monoxide in adult exhaled breath, typically for use in smoking cessation programs and for the screening of CO poisoning. The devices are controlled via a two button kevpad with the measured parameters displayed on a simple LCD with coloured lights and an accompanying buzzer sound in response to the CO level. Electrochemical sensor technology is utilized to sample the gas and a microprocessor converts the output from the sensor into a meaningful displayed result, either as carbon monoxide in parts per million (CO) or the percentage of carboxyhaemoglobin in the blood (%COHb). The breath sampling system that attaches directly to the carbon monoxide monitors, comprises of a non-patient contacting mouthpiece adapter incorporating a one way valve to prevent cross contamination and a single use, patient contacting cardboard mouthpiece. The mouthpiece adapter maybe replaced or reused as required. The Carbon monoxide monitors are supplied non sterile for use by healthcare professionals only and can also be used for ambient air monitoring.
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