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rockwell medical supply llc hemodialysis concentrate solutions powders
Rockwell Medical Supply
Summary: Hemodialysis concentrate solutions powders are used in dialysis to help filter waste from the blood. They are primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K954527 ↗
Decision Date
March 1, 1996
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 1, 1996, by Rockwell Medical Supply. It is classified as a Class 2 medical device under product code KPO.
What It Is
Hemodialysis concentrate solutions powders are essential components in the dialysis process. They are mixed with purified water to create a dialysate solution, which helps remove waste products and excess fluid from the blood of patients with kidney failure. This device is crucial for maintaining the electrolyte balance and overall stability of patients undergoing hemodialysis.
Clinical Applications
These solutions are commonly used in outpatient dialysis centers and hospitals where patients with chronic kidney disease receive treatment. Nephrologists and dialysis nurses use them to prepare dialysate solutions tailored to individual patient needs. The device is vital for patients with end-stage renal disease who require regular hemodialysis to manage their condition.
Indications for Use
The FDA indications for this device involve its use in hemodialysis treatment for patients with kidney failure. It is specifically designed to assist in the removal of waste products and excess fluids from the blood when the kidneys are no longer able to perform these functions adequately.
Practical Considerations
When using hemodialysis concentrate solutions powders, it is important to ensure proper mixing with purified water to achieve the correct concentration. Compatibility with dialysis machines and patient-specific electrolyte needs should be considered to optimize treatment outcomes.
Frequently Asked Questions
What is hemodialysis concentrate solutions powders used for?
It is used to create a dialysate solution that helps filter waste and excess fluid from the blood during hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis treatment for patients with kidney failure to assist in blood filtration.
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.