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U.S. Department of Health and Human Services

Product Classification
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Device extracorporeal circuit and accessories for long term respiratory cariodpulmonary failure
Definition Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure for patient having cardiopulmonary failure during the declared public health emergency.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel Cardiovascular
Product CodeQOD
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
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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