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510(k) Data Aggregation
K Number
K241268Device Name
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Manufacturer
Exceleron Medical
Date Cleared
2024-08-02
(88 days)
Product Code
BZE
Regulation Number
868.5270Why 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
K131626Device Name
EXCELERON BACTERIAL FILTERS
Manufacturer
EXCELERON MEDICAL
Date Cleared
2014-02-26
(267 days)
Product Code
CAH
Regulation Number
868.5260Why 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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