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nipro blood tubing set for hemodialysis with transducer protectors and priming set
Nipro Medical
Summary: The Nipro blood tubing set is used in hemodialysis to connect the patient's blood circulation to the dialysis machine. It is primarily used by nephrologists and dialysis technicians in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K010264 ↗
Decision Date
April 27, 2001
Product Code
FIB
Device Class
Class 2
Evidence
0 studies
The Nipro blood tubing set was cleared through the FDA 510(k) pathway on April 27, 2001. It is manufactured by Nipro Medical and classified as a Class 2 device under product code FIB.
What It Is
The Nipro blood tubing set is a medical device used in hemodialysis, consisting of tubes that transport blood from the patient to the dialysis machine and back. It includes transducer protectors to prevent contamination and a priming set to prepare the system for use. This device is essential for maintaining a sterile and efficient blood flow during dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers and hospitals during hemodialysis procedures. It is essential for patients with chronic kidney disease who require regular dialysis to filter waste from their blood. Nephrologists and dialysis technicians use this tubing set to ensure safe and effective dialysis treatment.
Indications for Use
The Nipro blood tubing set is indicated for use in patients undergoing hemodialysis, a treatment for those with end-stage renal disease or severe kidney dysfunction. It facilitates the connection between the patient's vascular access and the dialysis machine.
Practical Considerations
The tubing set is typically compatible with standard dialysis machines and comes in various lengths to accommodate different patient sizes and machine setups. Proper technique in connecting and priming the set is crucial to prevent air embolism and ensure effective dialysis.
Frequently Asked Questions
What is the Nipro blood tubing set used for?
It is used to connect a patient's blood circulation to a dialysis machine during hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis technicians in dialysis centers and hospitals use this device.
What are the FDA-cleared indications?
It is indicated for use in patients undergoing hemodialysis to facilitate blood flow between the patient and the dialysis machine.
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.