📋 FDA Reference
Mms Therpacplus B3DTUI Model Number 6 7
Multimedia Medical Systems
Summary: The mms therpacplus b3dtui model number 6 7 is a dialysis access device used primarily in nephrology for patients requiring dialysis. It is utilized by healthcare professionals in hospital and outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K982821 ↗
Decision Date ?
November 5, 1998
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on November 5, 1998, by Multimedia Medical Systems. It is classified as a Class 2 device under product code MUJ.
What It Is
The mms therpacplus b3dtui model number 6 7 is a medical device designed for dialysis access. It facilitates the process of hemodialysis by providing a reliable and efficient means of vascular access. The device is engineered to ensure compatibility with standard dialysis equipment and aims to minimize complications associated with vascular access.
FDA-Cleared Indications
- Vascular access for hemodialysis treatment, as described under FDA product code MUJ.
Clinical Applications
- Providing vascular access during hemodialysis.
- Use in patients who require dialysis access because of kidney failure or another condition requiring hemodialysis.
- Use in hospital or outpatient dialysis settings by trained healthcare professionals.
Practical Considerations
- The available FDA record identifies the device under product code MUJ but does not provide enough detail here to confirm specific dimensions, configuration, or patient-size ranges.
- Confirm device size, configuration, and compatibility with the intended dialysis equipment before use.
- Insertion, access, dressing changes, and maintenance should follow the manufacturer's instructions and standard aseptic technique.
- Assess for complications associated with dialysis vascular access, including infection, thrombosis, bleeding, malposition, and inadequate flow.
- MRI safety has not been established from the information provided; review the current labeling or contact the manufacturer before an MRI examination.
Frequently Asked Questions
What is mms therpacplus b3dtui model number 6 7 used for?
It is used to provide vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis centers commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring vascular access for dialysis treatments, such as those with chronic kidney disease.
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.