Definition: Disinfectant Intended For Reprocessing Water Purification Systems For Hemodialysis.
| Device Type ID | 2524 |
| Device Name | Disinfectant, Subsystem, Water Purification |
| Regulation Description | Water Purification System For Hemodialysis. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NIH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2524 |
| Device | Disinfectant, Subsystem, Water Purification |
| Product Code | NIH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Water Purification System For Hemodialysis. |
| CFR Regulation Number | 876.5665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDIVATORS REPROCESSING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 2 |