Heat/moisture exchanger/microbial filter, sterile
Access comprehensive regulatory information for Heat/moisture exchanger/microbial filter, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Koala Medical Pty Ltd, manufactured by Shaoxing Undis Medical Technology Co Ltd in China. The device registration started on February 26, 2020.
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A sterile device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient; it may also be intended for filtration of medical gases [e.g., carbon dioxide (CO2)] during insufflation. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. This is a single-use device.