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U.S. Department of Health and Human Services

Product Classification

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Device immunoadsorption column for emergency use
Definition Extracorporeal carbon dioxide removal from blood for use during declared public health emergency.
Physical State Blood or plasma filter comprised of hollow fibers or adsorption media, possibly including an extracorporeal tubing set and other accessories.
Technical Method Extracorporeal blood purification
Target Area Extracorporeal filtration of blood or plasma
Review Panel Gastroenterology/Urology
Product CodeQLO
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
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
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible