Emergency clearance from FDA for 3B products.
The FDA has given 3B Medical the go-ahead to use the UVC system on N95 respirators during the COVID-19 Pandemic.
The lumin was designed to clean CPAP accessories but can also be used as a multi-purpose sanitizer. The FDA has announced that it will allow N95 re-use to stop the spread of COVID-19 in health care workers, and that they will be able to use the drug in nursing homes uv phone sterilizer, long term acute care, ambulatory, primary care, and clinics.
The University of Nebraska Medical Center used UVC for N95 decontamination. The CDC recognized the potential of UVC to be used to decongest N95 respirators if the proper wavelength and UVC irradiance dose were used. The approved systems are limited to large hospitals and can be very expensive. The FDA has recognized the N95 system as the only one that can be used safely in small offices and clinics, as well as in nursing homes.
Alex Lucio, the CEO of 3B Medical, Inc said that the COVID-19 pandemic requires novel approaches and thinking outside the box. We were getting calls from hospitals and nursing homes asking if we could kill the disease. Studies show that the total output of the company is enough to kill almost any pathogen, including the one that causes the disease, the coronaviruses. A lot of the calls we get are from fire departments, nursing homes, and smaller community hospitals trying to keep their workers safe. The only device that is powered high enough to be used at home is the lumin. We are very excited to have our device approved by the FDA.
There have been shortages of N95 masks throughout the country. It is a game-changer to be able to re-use an N95 mask quickly and easily. Front line healthcare workers need an immediate solution to re-use their masks. The device is easy to use and fast, and we are glad it could be used to help in the crisis.
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