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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 ?
510(k)
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.
FDA-Cleared Indications
- Preparation of dialysate solutions for hemodialysis.
- Distribution of prepared dialysate solutions to hemodialysis equipment.
Clinical Applications
- Mixing water with dialysis concentrates to prepare dialysate.
- Distributing dialysate to hemodialysis machines in a dialysis facility.
- Supporting hemodialysis treatment for patients with kidney failure when used with compatible dialysis equipment.
Practical Considerations
- This is facility-based dialysis infrastructure, not an implanted or patient-worn device.
- The system must be used with appropriate water treatment, dialysis concentrates, distribution plumbing, and compatible hemodialysis machines.
- Operators should verify concentrate formulation, mixing ratios, water quality, pressure, flow, and alarm functions according to the manufacturer’s instructions and facility procedures.
- Regular cleaning, disinfection, maintenance, calibration, and microbiological or chemical quality checks are necessary to help prevent dialysate contamination or incorrect composition.
- MRI compatibility is generally not the primary consideration because the system is typically installed outside the MRI environment; local facility safety policies and the exact installation should be reviewed before placing equipment near an MRI scanner.
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.