đź“‹ FDA Reference
bvm hemodialysis blood tubing set with attached priming set and transducer protectors
Fresenius Medical Care North America, Design Cente
Summary: The BVM Hemodialysis Blood Tubing Set is used in hemodialysis procedures to facilitate blood flow between the patient and the dialysis machine. It is primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway 510K
Number K120823 ↗
Decision Date June 15, 2012
Product Code FJK
Device Class Class 2
Evidence 0 studies
The BVM Hemodialysis Blood Tubing Set by Fresenius Medical Care was cleared via the FDA 510(k) pathway on June 15, 2012. It is a Class 2 medical device.
What It Is
The BVM Hemodialysis Blood Tubing Set is a medical device designed to connect a patient to a hemodialysis machine, allowing for the removal of waste products from the blood. It includes a priming set and transducer protectors to ensure safe and effective dialysis treatment. The tubing set is essential for maintaining a sterile and efficient connection during dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers and hospitals during hemodialysis treatments. It is essential for patients with chronic kidney disease who require regular dialysis to manage their condition. Nephrologists and dialysis nurses use this tubing set to ensure proper blood flow and filtration during the procedure, making it a critical component in the management of renal failure.
Indications for Use
The FDA indications suggest that this tubing set is intended for patients undergoing hemodialysis, typically those with end-stage renal disease or acute kidney injury requiring renal replacement therapy.
Practical Considerations
The tubing set is typically compatible with standard hemodialysis machines and comes in various lengths to accommodate different patient sizes and machine setups. Proper priming and connection techniques are crucial to prevent air embolism and ensure patient safety.
Frequently Asked Questions
What is the BVM Hemodialysis Blood Tubing Set used for?
It is used to connect patients to a dialysis machine for hemodialysis treatment, facilitating blood flow and filtration.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis, such as those with chronic kidney disease or acute kidney injury.
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.