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U.S. Department of Health and Human Services

Product Classification

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Device normothermic preservation system for transplantation of initially unacceptable donor lungs
Definition Preservation of donor lungs for transplantation.
Physical State Device consists of a system made up of several components, such as the oxygenator, ventilator, thermal control unit, flow pumps, as well as the dedicated disposable sets, cannulation accessories, organ chamber and STEEN preservation solution.
Technical Method Device actively perfuses the donor lung with a preservation solution, while also ventilating and oxygenating it, and while maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation.
Target Area Donor lungs
Review Panel Gastroenterology/Urology
Product CodePHO
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible