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careline airless hemodialysis blood tubing sets
Fresenius Medical Care Renal Therapies Group
Summary: The Careline Airless Hemodialysis Blood Tubing Sets are used in hemodialysis procedures to transport blood between the patient and the dialysis machine. They are primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K172238 ↗
Decision Date
December 14, 2017
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Careline Airless Hemodialysis Blood Tubing Sets were cleared through the FDA 510(k) pathway on December 14, 2017. Manufactured by Fresenius Medical Care Renal Therapies Group, this device is classified as Class 2 under product code KOC.
What It Is
The Careline Airless Hemodialysis Blood Tubing Sets are specialized medical devices used in hemodialysis to facilitate the safe and efficient transport of blood between the patient and the dialysis machine. These tubing sets are designed to minimize air exposure and ensure a closed system, reducing the risk of air embolism. They are integral to the hemodialysis circuit, connecting the patient's vascular access to the dialyzer and back.
Clinical Applications
These tubing sets are commonly used in chronic and acute hemodialysis treatments, primarily within nephrology departments and dialysis centers. They are essential for patients with end-stage renal disease (ESRD) or acute kidney injury (AKI) requiring renal replacement therapy. The device is utilized by healthcare professionals, including nephrologists, dialysis nurses, and technicians, in both inpatient and outpatient settings.
Indications for Use
The Careline Airless Hemodialysis Blood Tubing Sets are indicated for use in patients requiring hemodialysis, a procedure to filter waste and excess fluids from the blood when the kidneys are not functioning properly. This includes patients with chronic kidney disease or acute kidney failure.
Practical Considerations
These tubing sets are typically compatible with a variety of dialysis machines and are available in different lengths to accommodate various clinical setups. Proper connection and priming techniques are crucial to ensure patient safety and device efficacy. Regular inspection for leaks or kinks is recommended during use.
Frequently Asked Questions
What is Careline Airless Hemodialysis Blood Tubing Sets used for?
They are used to transport blood between the patient and the dialysis machine during hemodialysis procedures.
What specialties typically use this device?
Nephrology and dialysis centers, involving nephrologists, dialysis nurses, and technicians.
What are the FDA-cleared indications?
For use in hemodialysis to filter waste and excess fluids from the blood in patients with kidney dysfunction.
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.