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ameriwater solution mix and distribution system for hemodialysis
Ameriwater
Summary: The Ameriwater Solution Mix and Distribution System is used in hemodialysis to prepare and distribute dialysate solutions. It is primarily used by nephrologists and dialysis technicians in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K051031 ↗
Decision Date
January 6, 2006
Product Code
FIN
Device Class
Class 2
Evidence
0 studies
The Ameriwater Solution Mix and Distribution System was cleared through the FDA 510(k) pathway on January 6, 2006. It is manufactured by Ameriwater and is classified as a Class 2 device under product code FIN.
What It Is
The Ameriwater Solution Mix and Distribution System is a medical device designed to prepare and distribute dialysate solutions used in hemodialysis. It ensures the precise mixing of water and concentrates to create a solution that can effectively cleanse the blood of patients with renal failure. The system is crucial for maintaining the correct chemical balance in the dialysate, which is essential for safe and effective dialysis treatment.
Clinical Applications
This device is commonly used in dialysis centers where patients with chronic kidney disease undergo hemodialysis. It is an integral part of the dialysis setup, ensuring that the dialysate solution is correctly prepared and delivered to the dialysis machines. Nephrologists and dialysis technicians rely on this system to provide consistent and safe dialysis treatment, particularly for patients with end-stage renal disease.
Indications for Use
The FDA-cleared indications for this device include its use in the preparation and distribution of dialysate solutions for hemodialysis. It is intended for patients requiring dialysis due to kidney failure or chronic kidney disease.
Practical Considerations
The system is typically compatible with standard dialysis machines and requires regular maintenance to ensure optimal performance. Clinicians should be aware of the specific concentrate formulations used and ensure that the system is calibrated correctly to maintain solution accuracy.
Frequently Asked Questions
What is the Ameriwater Solution Mix and Distribution System used for?
It is used to prepare and distribute dialysate solutions for hemodialysis.
What specialties typically use this device?
Nephrology and dialysis technicians in dialysis centers.
What are the FDA-cleared indications?
For the preparation and distribution of dialysate solutions in hemodialysis for patients with kidney failure.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.