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dora tubing sets for hemodialysis
Bain Medical Equipment (Guangzhou)
Summary: The dora tubing sets for hemodialysis are used in dialysis procedures to facilitate the removal of waste products from the blood. They are primarily utilized by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K161582 ↗
Decision Date
June 16, 2017
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The dora tubing sets for hemodialysis were cleared through the FDA 510(k) pathway on June 16, 2017. Manufactured by Bain Medical Equipment (Guangzhou), this device is classified as Class 2 under product code FJK.
What It Is
The dora tubing sets for hemodialysis are medical devices designed to connect a patient's vascular access to a dialysis machine. They are essential components in the hemodialysis process, allowing for the efficient transfer of blood to and from the dialysis machine, where waste products and excess fluids are removed. The tubing sets are typically made of biocompatible materials to minimize the risk of adverse reactions.
Clinical Applications
These tubing sets are commonly used in hemodialysis centers and hospitals, where patients with chronic kidney disease undergo regular dialysis sessions. Nephrologists and dialysis nurses use these devices to ensure safe and effective blood flow during the procedure. They are suitable for adult and pediatric patients requiring renal replacement therapy.
Indications for Use
The FDA indications for the dora tubing sets include use in hemodialysis procedures to facilitate blood flow between the patient and the dialysis machine. They are intended for patients with renal failure who require dialysis treatment.
Practical Considerations
The dora tubing sets are available in various lengths and configurations to accommodate different patient sizes and dialysis machine setups. They are compatible with standard hemodialysis machines and should be used according to the manufacturer's guidelines to ensure optimal performance and patient safety.
Frequently Asked Questions
What is dora tubing sets for hemodialysis used for?
They are used to connect a patient's vascular access to a dialysis machine, facilitating the removal of waste products from the blood during hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use these devices in hemodialysis centers and hospital settings.
What are the FDA-cleared indications?
The tubing sets are indicated for use in hemodialysis procedures to facilitate blood flow between the patient and the dialysis machine 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.