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 ?
510(k)
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.
FDA-Cleared Indications
- For use as a blood tubing set during hemodialysis procedures.
- For connection between the patient and a hemodialysis machine to allow extracorporeal blood flow.
- Includes components for priming the blood circuit and protecting dialysis machine pressure transducers.
Clinical Applications
- Connecting a patient’s vascular access to the arterial and venous sides of a hemodialysis circuit.
- Priming the extracorporeal blood tubing circuit before hemodialysis.
- Monitoring pressures during hemodialysis while protecting the dialysis machine’s transducers from blood contamination.
- Supporting routine hemodialysis treatment in a hospital or dialysis-center setting.
Practical Considerations
- Use only with a compatible hemodialysis machine and according to the device labeling and facility protocol.
- The tubing set is typically single-use and must be inspected for package damage, leaks, or contamination before use.
- Correct priming, connection, clamping, and removal of air are essential to reduce the risk of air embolism, blood loss, clotting, and infection.
- The tubing set does not provide vascular access; it connects to an existing access such as an arteriovenous fistula, graft, or dialysis catheter.
- This external tubing assembly is not an implanted device and is not independently evaluated for MRI compatibility; it should not be taken into the MRI environment while connected to a patient unless the complete setup has been cleared by the responsible facility.
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.