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*FDA’s enforcement policy for certain modifications to ventilators and accessories and other respiratory devices during COVID-19: https://www.fda.gov/media/136318/download | *FDA’s enforcement policy for certain modifications to ventilators and accessories and other respiratory devices during COVID-19: https://www.fda.gov/media/136318/download | ||
*Importation of a medical device: https://content.govdelivery.com/bulletins/gd/USDHSCBP-282c648?wgt_ref=USDHSCBP_WIDGET_2?utm_source=csms.cbp.gov&utm_medium=csms.cbp.gov&utm_term=undefined&utm_content=undefined&utm_campaign=(not%20set)&gclid=undefined&dclid=undefined&GAID=1278996374.1567630590 | *Importation of a medical device: https://content.govdelivery.com/bulletins/gd/USDHSCBP-282c648?wgt_ref=USDHSCBP_WIDGET_2?utm_source=csms.cbp.gov&utm_medium=csms.cbp.gov&utm_term=undefined&utm_content=undefined&utm_campaign=(not%20set)&gclid=undefined&dclid=undefined&GAID=1278996374.1567630590 | ||
===Safety Precautions=== | ===Safety Precautions=== | ||
* Confirm that the wiring in the ventilator is correctly set-up (see wiring diagram) | * Confirm that the wiring in the ventilator is correctly set-up (see wiring diagram) |