Definition: Preservation Of Donor Lungs For Transplantation.
| Device Type ID | 2231 |
| Device Name | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
| 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 |
| 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 Exem |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PHO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2231 |
| Device | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
| Product Code | PHO |
| FDA Device Classification | Class 3 Medical Device |