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nipro dry complete dry acid concentrate for hemodialysis
Nipro Renal Solutions U
Summary: The Nipro Dry Complete Dry Acid Concentrate is used in hemodialysis to prepare dialysate solutions. It is utilized by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K193155 ↗
Decision Date
November 25, 2020
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The Nipro Dry Complete Dry Acid Concentrate was cleared through the FDA 510(k) pathway on November 25, 2020. It is manufactured by Nipro Renal Solutions U and classified as a Class 2 device.
What It Is
This device is a dry acid concentrate used in the preparation of dialysate solutions for hemodialysis. It is designed to be mixed with bicarbonate and water to create a solution that helps remove waste products and excess fluid from the blood. The dry form allows for easier storage and handling compared to liquid concentrates, reducing the risk of spillage and contamination.
Clinical Applications
The Nipro Dry Complete Dry Acid Concentrate is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for patients with chronic kidney disease who require regular dialysis treatments. Nephrologists and dialysis nurses use this concentrate to ensure the dialysate is correctly balanced for effective treatment.
Indications for Use
This device is indicated for use in patients undergoing hemodialysis to manage kidney failure. It is specifically used to prepare the dialysate solution that interacts with the patient's blood during dialysis to remove toxins and excess fluids.
Practical Considerations
The dry acid concentrate is available in various formulations to match different dialysis machine requirements and patient needs. It is compatible with standard dialysis systems, and care should be taken to ensure proper mixing ratios with bicarbonate and water as per the manufacturer's instructions.
Frequently Asked Questions
What is Nipro Dry Complete Dry Acid Concentrate used for?
It is used to prepare dialysate solutions for hemodialysis, essential for removing waste and excess fluid from the blood of patients with kidney failure.
What specialties typically use this device?
Nephrology, particularly in dialysis centers and hospitals where hemodialysis is performed.
What are the FDA-cleared indications?
The device is indicated for preparing dialysate solutions for patients undergoing hemodialysis to manage 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.