21 CFR 876.5665 — Subsystem, Water Purification
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5665
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Classification Rationale
Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | 2 | 117 | 3rd Party |
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | 2 | 13 | Life-Sustaining |
| MSZ | Strip, Test, Reagent, Residuals For Dialysate | 2 | 0 | Life-Sustaining |
| NHV | System, Water Purification, General Medical Use | 2 | 11 | |
| NIH | Disinfectant, Subsystem, Water Purification | 2 | 1 | |
| PSX | Chlorine Meter | 2 | 1 | Life-Sustaining |
Special Controls
FIP — Subsystem, Water Purification
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
MSY — Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
MSZ — Strip, Test, Reagent, Residuals For Dialysate
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
NHV — System, Water Purification, General Medical Use
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
NIH — Disinfectant, Subsystem, Water Purification
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
PSX — Chlorine Meter
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
