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fresenius biocarb hemodialysis grade sodium bicarb
Fresenius U
Summary: The Fresenius Biocarb Hemodialysis Grade Sodium Bicarb is a medical device used in dialysis treatments to help maintain acid-base balance in patients with kidney failure. It is primarily used by nephrologists and dialysis technicians.
FDA Clearance Information
Pathway
510K
Number
K896111 ↗
Decision Date
December 27, 1989
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The Fresenius Biocarb Hemodialysis Grade Sodium Bicarb was cleared through the FDA 510(k) pathway on December 27, 1989. It is manufactured by Fresenius U and classified as a Class 2 device under product code KPO.
What It Is
This device is a hemodialysis-grade sodium bicarbonate used in dialysis treatments. It works by providing a bicarbonate buffer to the dialysis solution, which helps correct the acid-base imbalance commonly seen in patients with renal failure. The sodium bicarbonate is mixed with other components in the dialysate to help remove waste products and excess fluids from the blood.
Clinical Applications
The Fresenius Biocarb is commonly used in hemodialysis settings, particularly for patients with chronic kidney disease or acute renal failure. It is utilized in both in-center dialysis units and home dialysis setups. Nephrologists and dialysis nurses use this product to ensure that the dialysis solution has the appropriate chemical composition to effectively cleanse the blood.
Indications for Use
This device is indicated for use in patients undergoing hemodialysis who require correction of metabolic acidosis. It is suitable for individuals with chronic kidney disease or acute kidney injury who need dialysis to manage their condition.
Practical Considerations
The Fresenius Biocarb is typically available in powder form and must be mixed with water to prepare the dialysis solution. It is important to ensure compatibility with the dialysis machine being used and to follow proper mixing techniques to achieve the desired concentration.
Frequently Asked Questions
What is Fresenius Biocarb Hemodialysis Grade Sodium Bicarb used for?
It is used in dialysis treatments to help maintain acid-base balance in patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis technicians typically use this device in dialysis settings.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis to correct metabolic acidosis in 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.