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    K Number
    K241268
    Device Name
    Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
    Manufacturer
    Exceleron Medical
    Date Cleared
    2024-08-02

    (88 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    Exceleron Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THERMALITE® CPAP Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for adult patients. It is compatible with the Philips Respironics DreamStation 2 heated humidifiers.
    Device Description
    The Exceleron Medical, LLC (Exceleron) THERMALITE® CPAP Heated Tubing (THERMALITE) is a heated tube that connects between a continuous positive airway pressure (CPAP) machine and the patient's interface, typically a CPAP mask. The THERMALITE is compatible with the Philips Respironics DreamStation 1 and DreamStation 2 heated humidifiers. The THERMALITE has a unique design that helps prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form. This condition of condensation is commonly known as "rainout," and is usually the result of temperature and humidity differentials between the device versus the surrounding air. The THERMALITE is available in a three (3) or two (2) wire configuration.
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    K Number
    K131626
    Device Name
    EXCELERON BACTERIAL FILTERS
    Manufacturer
    EXCELERON MEDICAL
    Date Cleared
    2014-02-26

    (267 days)

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

    EXCELERON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility.
    Device Description
    A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit of a respiratory device. The filter is a replaceable accessory device used in oxygen concentrators, either as intake filters or final patient filters. The function of the oxygen concentrator machine is to draw room air into the machine's compressor and concentrate the oxygen content before delivering filtered, oxygen rich air to the patient. From the compressor, the filtered air proceeds to the sieve beds. The sieve beds in the oxygen concentrator machine condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final patient filter before being supplied to the patient. The Exceleron Medical bacterial intake filter and the final patient filter are intended to remove air borne bacteria and other particulate debris from the air stream.
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