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low-acetate hemodialysis bath concentr
Travenol Laboratories
Summary: The low-acetate hemodialysis bath concentr is a solution used in hemodialysis to help remove waste products from the blood. It is primarily used by nephrologists and dialysis technicians in clinical settings for patients with kidney failure.
FDA Clearance Information
Pathway
510K
Number
K800624 ↗
Decision Date
July 14, 1980
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The low-acetate hemodialysis bath concentr was cleared through the FDA 510k pathway on July 14, 1980. Manufactured by Travenol Laboratories, it is classified as a Class 2 device under product code KPO.
What It Is
This device is a concentrated solution used in hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. The low-acetate formulation helps to minimize complications such as metabolic acidosis and cardiovascular instability during dialysis sessions. It is mixed with purified water to create a dialysate solution that interacts with the patient's blood through a dialysis machine.
Clinical Applications
The low-acetate hemodialysis bath concentr is commonly used in dialysis centers and hospitals for patients with chronic kidney disease or acute kidney injury requiring dialysis. Nephrologists and dialysis nurses utilize this solution to maintain electrolyte balance and remove toxins from the bloodstream. It is particularly beneficial for patients who experience adverse reactions to standard acetate concentrations.
Indications for Use
This device is indicated for use in hemodialysis treatment for patients with renal failure. It is suitable for individuals who require dialysis to manage their kidney function and maintain metabolic balance.
Practical Considerations
The low-acetate hemodialysis bath concentr is typically available in various concentrations to accommodate different dialysis machines and patient needs. Compatibility with specific dialysis machines should be verified. Proper mixing and handling techniques are essential to ensure patient safety and treatment efficacy.
Frequently Asked Questions
What is the low-acetate hemodialysis bath concentr used for?
It is used in hemodialysis to help remove waste products and excess fluids from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrology and dialysis technicians typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis treatment for patients with renal failure to manage kidney function and maintain metabolic balance.
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.