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U.S. Department of Health and Human Services

Product Classification
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Device normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Definition The device is intended for machine preservation of donor livers prior to transplantation.
Physical State Device consists of a system made up of several components, such as an oxygenator, thermal control unit, a flow pump, as well as dedicated disposable sets, cannulation accessories, and organ chamber. Bile salts are included with the device.
Technical Method Device actively perfuses the donor liver with a preservation solution, while also oxygenating it, collecting bile and maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation.
Target Area Donor livers
Review Panel Gastroenterology/Urology
Product CodeQQK
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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