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U.S. Department of Health and Human Services

Product Classification

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Device intensive care unit, respiratory failure and hemodynamic instability tool
Definition To be used by healthcare providers in the Intensive Care Unit (ICU) for adult patients for the computation of patient status indices as an adjunct to patient monitoring during the declared public health emergency.
Physical State Software
Technical Method Software algorithm
Target Area Cardiopulmonary system
Review Panel Cardiovascular
Product CodeQLM
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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