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bioteque 3 in 1 hemodialysis blood tubing pack
Bioteque
Summary: The Bioteque 3 in 1 Hemodialysis Blood Tubing Pack is a medical device used in hemodialysis procedures to facilitate blood circulation between the patient and the dialysis machine. It is primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K013634 ↗
Decision Date
July 9, 2002
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Bioteque 3 in 1 Hemodialysis Blood Tubing Pack was cleared through the FDA 510(k) pathway on July 9, 2002. Manufactured by Bioteque, it is classified as a Class 2 device under product code FJK.
What It Is
This device is a blood tubing set designed for use in hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. The tubing pack typically includes arterial and venous lines that connect the patient's vascular access to the dialysis machine, ensuring safe and efficient blood circulation during treatment.
Clinical Applications
The Bioteque 3 in 1 Hemodialysis Blood Tubing Pack is commonly used in dialysis centers and hospitals during hemodialysis sessions. It is essential for patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy. Nephrologists and dialysis nurses utilize this device to manage patients' blood filtration needs effectively.
Indications for Use
The device is indicated for patients undergoing hemodialysis, particularly those with end-stage renal disease or acute kidney failure. It facilitates the safe transfer of blood to and from the dialysis machine, ensuring effective treatment.
Practical Considerations
The tubing pack is available in various sizes to accommodate different patient needs and machine compatibilities. Clinicians should ensure proper connection and secure fittings to prevent leaks or disconnections during dialysis. Compatibility with the dialysis machine and vascular access type should be verified before use.
Frequently Asked Questions
What is the Bioteque 3 in 1 Hemodialysis Blood Tubing Pack used for?
It is used in hemodialysis to connect the patient's blood circulation to the dialysis machine for blood filtration.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis procedures for patients requiring blood filtration 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.