Data / Medical devices / Disinfectant, Dialysate Delivery System
Disinfectant, Dialysate Delivery System (NII): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Disinfectant, Dialysate Delivery System (product code NII, Class 2, 21 CFR 876.5860). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on November 4, 2005, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NII
- Device class
- 2
- Regulation
- 876.5860
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 2 |
| Germany | 2 |
| Canada | 1 |
Makers of Disinfectant, Dialysate Delivery System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Evoqua Water Technologies LLC | Minneapolis, MN, United States | Manufacturer | 1 | November 4, 2005 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Deutschland GMBH | ST. WENDEL Saarland, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Deutschland GMBH | SCHWEINFURT Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius USA Manufacturing, Inc. | Oregon, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotec, a division of Fresenius Medical Care Canada Inc. | VAUDREUIL-DORION Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 4, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.