Dialysis Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dialysis Systems, Inc. makes
Dialysis Systems, Inc. manufactures the NEPHROSOL, a sterile, pyrogen-free dialysis solution used in hemodialysis procedures, and the BICARD MIXING SYSTEM, a device designed for preparing and mixing dialysis concentrates. These products support renal replacement therapy by providing controlled fluid and electrolyte solutions for patient treatment.
The company’s portfolio is regulated under FDA Class II devices, requiring premarket notification (510(k)) clearance. The devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Nephrosol Ref K822244
Regimes: 510(k) Registry: 510(k)Bicard Mixing System Ref K030366
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dialysis Systems, Inc. have in the registry?
The registry currently lists 2 devices for Dialysis Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dialysis Systems, Inc.'s devices?
Among its 2 most recently registered devices, Dialysis Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dialysis Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dialysis Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dialysis Systems, Inc. in the registry?
The most recently registered devices listed for Dialysis Systems, Inc. include NEPHROSOL and BICARD MIXING SYSTEM.