📋 FDA Reference
Nmc Hemodialysis Arterial Blood Tubing Set
National Medical Care
Summary: The NMC Hemodialysis Arterial Blood Tubing Set is used in hemodialysis to transport blood from the patient to the dialysis machine. It is primarily used by nephrologists and dialysis nurses in dialysis centers and hospitals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K971313 ↗
Decision Date ?
October 27, 1997
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The NMC Hemodialysis Arterial Blood Tubing Set was cleared through the FDA 510k pathway on October 27, 1997. Manufactured by National Medical Care, it is a Class 2 medical device.
What It Is
The NMC Hemodialysis Arterial Blood Tubing Set is a medical device used in hemodialysis procedures. It consists of tubing that connects the patient's vascular access to the dialysis machine, allowing blood to be transported for filtration. The device is designed to handle the high flow rates required during dialysis and is typically made from biocompatible materials to minimize adverse reactions.
FDA-Cleared Indications
- For use in hemodialysis procedures to transport arterial blood from the patient's vascular access to the dialysis machine.
- For use with compatible hemodialysis equipment and vascular access systems.
Clinical Applications
- Connecting a patient's arterial dialysis access to the blood inlet of a hemodialysis machine.
- Transporting blood through the extracorporeal circuit during hemodialysis.
- Use during intermittent hemodialysis in dialysis centers or hospitals when the patient requires blood filtration.
Practical Considerations
- Confirm that the tubing set is compatible with the dialysis machine, blood pump, connectors, and prescribed extracorporeal circuit.
- Select the appropriate tubing length and configuration for the patient, access arrangement, and dialysis equipment.
- Use aseptic technique during setup and follow the manufacturer's instructions for priming, connection, monitoring, and disposal.
- This is generally a single-use blood-contacting component; do not reuse unless the product labeling and applicable institutional policies specifically permit it.
- MRI safety depends on the complete setup and any attached components. The tubing itself is not a treatment device for MRI, and it should not be taken into the MRI environment without verified site-specific MR safety information.
Frequently Asked Questions
What is the NMC Hemodialysis Arterial Blood Tubing Set used for?
It is used to transport blood from the patient to the dialysis machine during hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses typically 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 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.