| Device Type ID | 1947 |
| Device Name | Container, Transport, Kidney |
| Regulation Description | Isolated Kidney Perfusion And Transport System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 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 | 510(k) |
| CFR Regulation Number | 876.5880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KDK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1947 |
| Device | Container, Transport, Kidney |
| Product Code | KDK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Isolated Kidney Perfusion And Transport System And Accessories. |
| CFR Regulation Number | 876.5880 [🔎] |