• The IntelliVue Active Display AD75 and AD85 in combination with the IntelliVue MX750 and MX850 patient monitors have neither been cleared or approved for the indication to assist in for monitoring and recording of, and for generating alarms for, multiple physiological parameters of adult, pediatric, and neonate patients having or suspected of having Coronavirus-2019 (COVID-19); and, 
  • The IntelliVue Active Display AD75 and AD85 in combination with the IntelliVue MX750 and MX850 patient monitors have been authorized for the above emergency use by FDA under an EUA; 
  • The IntelliVue Active Display AD75 and AD85 in combination with the IntelliVue MX750 and MX850 patient monitors have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.