Data / Medical devices / Disinfectant, Subsystem, Water Purification
Disinfectant, Subsystem, Water Purification (NIH): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Disinfectant, Subsystem, Water Purification (product code NIH, Class 2, 21 CFR 876.5665). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 27, 2014, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NIH
- Device class
- 2
- Regulation
- 876.5665
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Disinfectant, Subsystem, Water Purification
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 |
|---|---|---|---|---|---|---|---|---|
| Medivators Inc | Minneapolis, MN, United States | Manufacturer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Mentor, OH, United States | Specification developer | 1 | August 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Nomax, Inc. | Affton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 27, 2014. 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.