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dialysate concentrate for hemodialysis-liquid powd
Renal Systems
Summary: The dialysate concentrate for hemodialysis by Renal Systems is used in dialysis treatments to help filter waste from the blood in patients with kidney failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K843963 ↗
Decision Date
January 7, 1985
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
This dialysate concentrate was cleared through the FDA 510(k) pathway on January 7, 1985. Manufactured by Renal Systems, it is classified as a Class 2 device under product code FKQ.
What It Is
The dialysate concentrate for hemodialysis is a medical solution used to create the dialysate fluid necessary for dialysis treatments. It works by mixing with purified water to form a solution that helps remove waste products and excess fluids from the blood of patients with renal failure. This process mimics the natural function of the kidneys, which is compromised in these patients.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease undergo regular hemodialysis. Nephrologists and dialysis nurses use it to prepare the dialysate solution required for the dialysis process. It is crucial for patients who require long-term dialysis treatment due to end-stage renal disease.
Indications for Use
The dialysate concentrate is indicated for use in hemodialysis to treat patients with kidney failure. It is specifically used to help filter and clean the blood when the kidneys are no longer able to perform this function adequately.
Practical Considerations
Dialysate concentrates are typically available in liquid or powder form and must be mixed with purified water before use. Compatibility with dialysis machines and proper mixing techniques are essential to ensure patient safety and treatment efficacy.
Frequently Asked Questions
What is dialysate concentrate for hemodialysis used for?
It is used to prepare the dialysate solution needed for hemodialysis, which helps filter waste and excess fluid from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrology and dialysis centers primarily use this device, with nephrologists and dialysis technicians being the main users.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis to treat patients with kidney failure, assisting in blood filtration when the kidneys are unable to do so.
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.