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modification to dryac acid concentrate mix for bicarbonate hemodialysis
Gambro Renal Products
Summary: The Dryac Acid Concentrate Mix is a modification used in bicarbonate hemodialysis, primarily for patients with renal failure. It is utilized by nephrologists and dialysis clinicians in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K052253 ↗
Decision Date
November 2, 2005
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The Dryac Acid Concentrate Mix was cleared through the FDA 510(k) pathway on November 2, 2005. It is manufactured by Gambro Renal Products and classified as a Class 2 device under product code KPO.
What It Is
The Dryac Acid Concentrate Mix is a formulation used in bicarbonate hemodialysis, a process that helps remove waste products and excess fluid from the blood when the kidneys are not functioning properly. It works by mixing with bicarbonate to create a dialysate solution that balances electrolytes and removes toxins. This device is essential in maintaining the acid-base balance during dialysis treatment.
Clinical Applications
This device is commonly used in dialysis centers for patients with chronic kidney disease or acute renal failure requiring hemodialysis. Nephrologists and dialysis nurses use it to prepare dialysate solutions tailored to individual patient needs. It is crucial in managing patients with electrolyte imbalances and those undergoing regular dialysis sessions.
Indications for Use
The FDA indications for this device include its use in bicarbonate hemodialysis to treat patients with kidney failure. It is specifically indicated for creating dialysate solutions that help in the removal of waste products and excess fluids.
Practical Considerations
The Dryac Acid Concentrate Mix is typically available in various formulations to accommodate different patient needs. It is compatible with most standard dialysis machines and requires precise mixing with bicarbonate. Clinicians should ensure proper storage and handling to maintain efficacy.
Frequently Asked Questions
What is Dryac Acid Concentrate Mix used for?
It is used in bicarbonate hemodialysis to help remove waste products and balance electrolytes in patients with renal failure.
What specialties typically use this device?
Nephrologists and dialysis clinicians in dialysis centers typically use this device.
What are the FDA-cleared indications?
It is indicated for use in bicarbonate hemodialysis to treat patients with kidney failure by creating dialysate solutions.
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.