WIN Health Labs, LLC
This is a Public Health Emergency (PHE) Particulate Filtering Respirator, which the U.S. National Institute for Occupational Safety and Health (NIOSH) authorized as a Limited Public Health Emergency Powered AirPurifying Respirator (PAPR) on a temporary basis. The U.S. Food and Drug Administration (FDA) authorized the emergency use of this PAPR only in healthcare settings by healthcare personnel when used in accordance with the U.S. Centers for Disease Control and Prevention (CDC) recommendations to help prevent wearer exposure to pathogenic biological airborne particulates during respirator shortages resulting from the Coronavirus Disease (COVID-19) outbreak.
The FDA Emergency Use Authorization (EUA) does not permit use of this product by the general public and should not be used in non-healthcare applications.
This PAPR System is intended to be used only during the declared public health emergency associated with the novel coronavirus (SARS-CoV-2) that causes COVID-19, and only by appropriately trained and supervised healthcare personnel who have read and understood the User Instructions and follow their organization’s requirements and instructions.
At the end of the current public health emergency, or in the event the FDA revokes the current emergency use authorization or NIOSH revokes their temporary authorization, this respirator should be removed from service immediately.
This respirator should be properly disposed of on or before the expiration date. Disposal of this respirator, including the battery, must follow the process specified by WIN Health Labs and the battery manufacturer.
NOTICE September 3, 2020:
Following further review or our PAPRs, we are extending the Expiration Date of all of our PAPRs to December 31, 2020.
We will continue to review the PAPR and may further extend the Expiration Dates as appropriate.