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surdial dx hemodialysis system
Nipro Medical
Summary: The Surdial DX Hemodialysis System is a medical device used for hemodialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K182940 ↗
Decision Date
July 19, 2019
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Surdial DX Hemodialysis System was cleared through the FDA 510(k) pathway on July 19, 2019. It is manufactured by Nipro Medical and classified as a Class 2 device under product code KDI.
What It Is
The Surdial DX Hemodialysis System is an advanced hemodialysis machine designed to filter waste products and excess fluids from the blood of patients with kidney failure. It operates by circulating the patient's blood through a dialyzer, where diffusion and osmosis remove toxins and balance electrolytes. This system is equipped with features to enhance patient safety and treatment efficiency, making it a reliable choice for dialysis centers.
Clinical Applications
This device is commonly used in outpatient dialysis centers and hospital dialysis units. It is essential for the management of patients with chronic kidney disease (CKD) or acute kidney injury (AKI) who require renal replacement therapy. Nephrologists and dialysis nurses use it to perform routine dialysis sessions, typically three times a week, to maintain the patient's health and quality of life.
Indications for Use
The FDA indications for the Surdial DX Hemodialysis System include its use in patients with end-stage renal disease (ESRD) or acute kidney injury who need hemodialysis. It is suitable for adult patients who require regular dialysis treatments to manage their renal function.
Practical Considerations
The Surdial DX system is compatible with standard dialysis consumables, including dialyzers and bloodlines. It offers various treatment modes and customizable settings to accommodate different patient needs. Clinicians should be familiar with its user interface and safety features to optimize treatment outcomes.
Frequently Asked Questions
What is the Surdial DX Hemodialysis System used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste products and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses in nephrology and renal care settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with end-stage renal disease or acute kidney injury who require hemodialysis treatment.
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.