ABSTRACT

Fact Sheet for Healthcare Providers: Emergency Use of the COViage System During the COVID-19 Pandemic   [open pdf - 199KB]

From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the 'COViage' System (or 'COViage') for use by healthcare providers (HCP) in the hospital setting for adult patients (18 years of age or older who are admitted to the hospital) with confirmed COVID-19 [coronavirus disease 2019] (based on a positive PCR [polymerase chain reaction] test result) for the computation of proprietary patient status indices referred to as Respiratory Decompensation Status and Hemodynamic Instability Status as an adjunct to patient monitoring during the COVID-19 outbreak. The COViage indices provide HCP with predictive screening information as a diagnostic aid to assist with the early identification of COVID-19 patients who are likely to be diagnosed with hemodynamic instability or respiratory decompensation, which are common complications associated with COVID-19."

Publisher:
Date:
2020-09-24
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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