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spot pro 220v model 131 099
Nucletron
Summary: The Spot Pro 220V Model 131 099 by Nucletron is a dialysis access device used primarily in nephrology to facilitate efficient dialysis treatment. It is designed for use by healthcare professionals in clinical settings.
FDA Clearance Information
Pathway 510K
Number K022741 ↗
Decision Date October 24, 2002
Product Code MUJ
Device Class Class 2
Evidence 0 studies
The Spot Pro 220V Model 131 099 was cleared through the FDA 510k pathway on October 24, 2002. Manufactured by Nucletron, it is classified as a Class 2 medical device under product code MUJ.
What It Is
The Spot Pro 220V Model 131 099 is a medical device designed to assist in dialysis procedures by providing reliable access to the patient's circulatory system. It is engineered to ensure stable and efficient blood flow during dialysis, which is critical for patients with renal failure. The device is typically used in conjunction with other dialysis equipment to optimize treatment outcomes.
Clinical Applications
This device is commonly used in nephrology departments and dialysis centers. It is essential for patients requiring regular dialysis due to chronic kidney disease or acute renal failure. The device is used by nephrologists and trained dialysis nurses to ensure safe and effective dialysis sessions, particularly in outpatient settings where routine dialysis is performed.
Indications for Use
The FDA-cleared indications for the Spot Pro 220V Model 131 099 include its use in patients needing dialysis access. This typically involves patients with end-stage renal disease or those who require temporary dialysis due to acute kidney injury.
Practical Considerations
When using the Spot Pro 220V Model 131 099, clinicians should consider compatibility with existing dialysis machines and ensure proper sizing for the patient. It is important to follow the manufacturer's guidelines for installation and maintenance to ensure optimal performance and patient safety.
Frequently Asked Questions
What is Spot Pro 220V Model 131 099 used for?
The device is used to provide access for dialysis treatment, facilitating efficient blood flow during the procedure.
What specialties typically use this device?
Nephrology and dialysis centers are the primary users of this device, with nephrologists and dialysis nurses being the main operators.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring dialysis access, such as those with chronic kidney disease or acute renal 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.