📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in the preparation of bicarbonate-containing dialysate for hemodialysis.
- Use during hemodialysis treatment to provide bicarbonate buffering as part of the dialysis solution.
- Use in patients receiving hemodialysis when bicarbonate-based dialysate is prescribed by the treating clinician.
Clinical Applications
- Preparation of dialysate for in-center hemodialysis.
- Preparation of dialysate for prescribed home hemodialysis.
- Bicarbonate replacement in the dialysate used to treat patients with kidney failure who require hemodialysis.
- Use with a compatible dialysis system according to the product labeling and dialysis-machine instructions.
Practical Considerations
- The product is supplied as a hemodialysis-grade sodium bicarbonate preparation, commonly in powder form, and must be prepared according to the labeling and dialysis-unit procedures.
- It must be mixed with the specified water and other dialysate components at the prescribed concentration; incorrect preparation can make the dialysate unsafe.
- Compatibility with the dialysis machine, concentrate system, water quality, and other dialysate components must be confirmed before use.
- Handling and preparation require trained dialysis personnel and appropriate infection-control procedures.
- This is a dialysis-solution component, not an intravenous medication or a standalone treatment for metabolic acidosis.
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.