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nipro arterial venous blood tubing set for hemodialysis
Nissho
Summary: The Nipro Arterial Venous Blood Tubing Set is used in hemodialysis to facilitate blood flow between the patient and the dialysis machine. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K954676 ↗
Decision Date
March 4, 1997
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Nipro Arterial Venous Blood Tubing Set was cleared via the FDA 510(k) pathway on March 4, 1997. It is manufactured by Nissho and classified as a Class II device under product code KOC.
What It Is
The Nipro Arterial Venous Blood Tubing Set is a medical device designed to connect a patient's vascular access to a hemodialysis machine. It consists of flexible tubing that allows for the safe and efficient transfer of blood to and from the dialysis machine, where it is filtered and cleaned. This device is crucial for patients undergoing hemodialysis, as it ensures the proper circulation and return of blood during the procedure.
Clinical Applications
This tubing set is commonly used in dialysis centers and hospitals during hemodialysis sessions. It is essential for patients with chronic kidney disease who require regular dialysis to manage their condition. Nephrologists and dialysis technicians employ this device to ensure effective blood purification, typically in adult and elderly patient populations, although it can be used for pediatric patients as well.
Indications for Use
The device is indicated for use in hemodialysis, which is a treatment for patients with end-stage renal disease or severe chronic kidney disease. It is specifically designed to facilitate the safe and efficient transfer of blood between the patient and the dialysis machine.
Practical Considerations
The tubing set is available in various sizes to accommodate different patient needs and machine specifications. It is important to ensure compatibility with the dialysis machine being used. Proper connection technique is crucial to prevent leaks and ensure patient safety during dialysis sessions.
Frequently Asked Questions
What is the Nipro Arterial Venous Blood Tubing Set used for?
It is used to connect a patient's vascular access to a hemodialysis machine, facilitating blood flow during dialysis.
What specialties typically use this device?
Nephrologists and dialysis technicians primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis to facilitate blood transfer 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.