Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This
| Device Type ID | 2100 |
| Device Name | Kidney Perfusion Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This |
| 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 | Enforcement Discretion |
| CFR Regulation Number | 876.5880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2100 |
| Device | Kidney Perfusion Kit |
| Product Code | PIN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Isolated Kidney Perfusion And Transport System And Accessories. |
| CFR Regulation Number | 876.5880 [🔎] |
| Device Problems | |
|---|---|
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
| Total Device Problems | 1 |