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U.S. Department of Health and Human Services

Product Classification
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Device continuous ventilator
Definition Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel Ear Nose & Throat
Product CodeQOS
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
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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