NOTICE FOR HEALTHCARE FACILITIES AND HEALTHCARE WORKERS
On December 3, 2020, The U.S. Food & Drug Administration issued Emergency Use Authorization to allow Lumin to be used in Healthcare Facilities to permit re-use of N95 respirators. FDA’s order finds that “the scope of this authorization is limited to the use of the Lumin LM3000, for use in bioburden reduction of compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, for a maximum of 4 bioburden reduction cycles per respirator or 5 donnings, whichever comes first, for single-user reuse by HCP to supplement CDC reuse recommendations to prevent exposure to pathogenic biological airborne particulates during the COVID-19 pandemic“. See FDA Emergency Use Authorization dated December 3, 2020.
Priority for Lumin sales is being provided to healthcare facilities and healthcare workers on the front lines. If you are a healthcare worker or healthcare facility, please click on this link to be redirected to our information and ordering page for healthcare facilities: https://www.3blumin.com/healthcare/