đź“‹ FDA Reference
nipro blood tubing set with transducer and solution set for hemodialysis
Nipro Medical
Summary: The Nipro Blood Tubing Set with Transducer and Solution Set is a medical device used in hemodialysis to facilitate the safe and efficient transfer of blood between the patient and the dialysis machine. It is primarily used by nephrologists and dialysis technicians.
FDA Clearance Information
Pathway
510K
Number
K972206 ↗
Decision Date
November 26, 1997
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Nipro Blood Tubing Set was cleared through the FDA 510k pathway on November 26, 1997. It is manufactured by Nipro Medical and is classified as a Class 2 device under product code KOC.
What It Is
The Nipro Blood Tubing Set is an essential component of the hemodialysis process, comprising tubing that connects the patient's vascular access to the dialysis machine. It includes a transducer and solution set to monitor and regulate pressure and fluid dynamics during dialysis. This device ensures the safe transport of blood to and from the patient, maintaining sterility and minimizing the risk of contamination.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is utilized by healthcare professionals specializing in nephrology to treat patients with chronic kidney disease or acute kidney injury requiring dialysis. The tubing set is integral to the dialysis procedure, ensuring efficient blood flow and proper monitoring of dialysis parameters.
Indications for Use
The FDA indications for this device include its use in patients requiring hemodialysis, typically those with end-stage renal disease or acute kidney failure. It is designed to facilitate the extracorporeal circulation of blood during dialysis sessions.
Practical Considerations
Clinicians should ensure compatibility of the tubing set with the specific dialysis machine being used. Proper technique in connecting and securing the tubing is crucial to prevent leaks or disconnections. The device is available in various sizes to accommodate different patient needs.
Frequently Asked Questions
What is the Nipro Blood Tubing Set used for?
It is used to connect the patient's blood circulation to the dialysis machine during hemodialysis.
What specialties typically use this device?
Nephrology and dialysis technicians commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis to facilitate extracorporeal blood circulation in patients with 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.