Definition: To Preserve Donor Lungs Prior To Transplantation
| Device Type ID | 2235 |
| Device Name | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Physical State | The Device May Consists Of A Portable Enclosure With Electronics And Hardcore That Control The Ventilation And Perfusion Of The Donor Organ, Disposable Components That Complete The Ventilation And Perfusion Circuits, And A Preservation Solution Used |
| Technical Method | The Device Perfuses And Ventilates The Donor Lungs Prior To Transplantation |
| Target Area | Donor Lungs |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QBA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2235 |
| Device | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Product Code | QBA |
| FDA Device Classification | Class 3 Medical Device |