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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 patients to dialysis machines. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K001465 ↗
Decision Date
December 5, 2000
Product Code
FIB
Device Class
Class 2
Evidence
0 studies
The Nipro Blood Tubing Set was cleared through the FDA 510(k) pathway on December 5, 2000. Manufactured by Nipro Medical, it is 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 procedures. It consists of tubes that connect the patient's vascular access to the dialysis machine, allowing blood to flow to and from the machine for filtration. The set includes transducer protectors and a priming set, which help ensure safe and efficient operation by preventing contamination and facilitating the priming process.
Clinical Applications
This device is commonly used in dialysis centers and hospitals during hemodialysis sessions. It is essential for patients with chronic kidney disease who require regular dialysis. Nephrologists and dialysis nurses use this tubing set to ensure safe and effective blood filtration, crucial for patients with end-stage renal disease or acute kidney injury.
Indications for Use
The Nipro Blood Tubing Set is indicated for use in patients undergoing hemodialysis. It is designed to facilitate the safe and effective connection between the patient and the dialysis machine, ensuring proper blood flow and filtration.
Practical Considerations
The tubing set is typically available in various lengths and configurations to accommodate different patient sizes and dialysis machines. It is important to ensure compatibility with the specific dialysis machine in use. Proper technique in connecting and priming the tubing is crucial to prevent air embolism and ensure patient safety.
Frequently Asked Questions
What is the Nipro Blood Tubing Set used for?
It is used to connect patients to dialysis machines during hemodialysis, allowing blood to be filtered and returned to the patient.
What specialties typically use this device?
Nephrology and dialysis nursing are the primary specialties that use this device in clinical settings.
What are the FDA-cleared indications?
The device 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.