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bicarb-o-mate hemodialysis sod bicarb
Renal Systems
Summary: The Bicarb-o-mate Hemodialysis Sod Bicarb is a medical device used in hemodialysis to maintain acid-base balance in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K802465 ↗
Decision Date
November 12, 1980
Product Code
FKR
Device Class
Class 2
Evidence
0 studies
The Bicarb-o-mate Hemodialysis Sod Bicarb was cleared through the FDA 510k pathway on November 12, 1980. Manufactured by Renal Systems, it is classified as a Class 2 device under product code FKR.
What It Is
The Bicarb-o-mate Hemodialysis Sod Bicarb is a bicarbonate solution used in hemodialysis machines to help maintain the acid-base balance in patients undergoing dialysis. It works by providing a source of bicarbonate ions, which are crucial for neutralizing acid in the blood. This is particularly important for patients with kidney failure, who cannot adequately regulate their blood pH levels.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease or acute kidney injury receive hemodialysis. Nephrologists and dialysis nurses use it to ensure that patients maintain proper blood pH levels during treatment. It is critical for patients who are unable to excrete acid through their kidneys, thus preventing metabolic acidosis.
Indications for Use
The Bicarb-o-mate is indicated for use in patients undergoing hemodialysis who require bicarbonate supplementation to maintain acid-base balance. It is suitable for individuals with renal failure who cannot regulate their blood pH naturally.
Practical Considerations
The device is typically compatible with standard hemodialysis machines and comes in various concentrations to suit different patient needs. Clinicians should ensure proper mixing and concentration according to the dialysis prescription to avoid complications such as alkalosis.
Frequently Asked Questions
What is Bicarb-o-mate Hemodialysis Sod Bicarb used for?
It is used to maintain acid-base balance in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis technicians use this device in clinical settings.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis to provide bicarbonate supplementation for patients with renal 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.