Gambro Renal Care Products
Country not established
- Devices
- 2
What Gambro Renal Care Products makes
Gambro Renal Care Products manufactures hemodialysis devices, including the GAMBRO POLYFLUX series (models 140H, 170H, 210H) for blood filtration, and the PRISMA Continuous Fluid Management System for managing fluid balance during dialysis treatments.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the United States.
Catalogue
Gambro Polyflux, Model 140H, 170H, 210H Ref K030592
Regimes: 510(k) Registry: 510(k)Prisma Cfm (Continuous Fluid Management System) Ref K993064
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gambro Renal Care Products have in the registry?
The registry currently lists 2 devices for Gambro Renal Care Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gambro Renal Care Products's devices?
Among its 2 most recently registered devices, Gambro Renal Care Products has devices listed in FDA 510(k) (2 devices).
What risk classes do Gambro Renal Care Products's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gambro Renal Care Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gambro Renal Care Products in the registry?
The most recently registered devices listed for Gambro Renal Care Products include GAMBRO POLYFLUX, MODEL 140H, 170H, 210H and PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM).