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bioteque hemodialysis blood tubing set
Bioteque
Summary: The Bioteque Hemodialysis Blood Tubing Set is a medical device used in hemodialysis procedures to transport blood 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
K992930 ↗
Decision Date
February 9, 2000
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Bioteque Hemodialysis Blood Tubing Set was cleared through the FDA 510(k) pathway on February 9, 2000. Manufactured by Bioteque, this device is classified as a Class 2 medical device under product code FJK.
What It Is
The Bioteque Hemodialysis Blood Tubing Set is designed to facilitate the safe and efficient transfer of blood from the patient to the dialysis machine and back. It consists of flexible tubing that connects to the patient's vascular access and the dialysis machine, ensuring a closed circuit for blood filtration. This device is crucial in maintaining the sterility and integrity of the blood during hemodialysis sessions.
Clinical Applications
This tubing set is commonly used in outpatient dialysis centers and hospitals where hemodialysis is performed. It is essential for patients with chronic kidney disease requiring regular dialysis treatments. Nephrologists and dialysis nurses use this device to manage and monitor the dialysis process, ensuring effective blood purification and patient safety.
Indications for Use
The Bioteque Hemodialysis Blood Tubing Set is indicated for use in patients undergoing hemodialysis, a process necessary for those with impaired kidney function. It is suitable for adult and pediatric patients who require blood filtration due to kidney failure.
Practical Considerations
The tubing set is available in various lengths and configurations to accommodate different dialysis machines and patient needs. It is compatible with standard hemodialysis equipment and requires proper connection techniques to ensure patient safety and device efficacy.
Frequently Asked Questions
What is the Bioteque Hemodialysis Blood Tubing Set used for?
It is used to transport blood between the patient and the dialysis machine during hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis technicians typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
It is indicated for use in patients undergoing hemodialysis due to 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.