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nipro safetouch safety fistula needle
Nipro Medical
Summary: The Nipro SafeTouch Safety Fistula Needle is a medical device used primarily in dialysis settings to access a patient's vascular system. It is designed for use by healthcare professionals specializing in nephrology and dialysis.
FDA Clearance Information
Pathway 510K
Number K002813 ↗
Decision Date November 21, 2000
Product Code FIE
Device Class Class 2
Evidence 0 studies
The Nipro SafeTouch Safety Fistula Needle was cleared through the FDA 510(k) pathway on November 21, 2000. It is manufactured by Nipro Medical and classified as a Class 2 device under product code FIE.
What It Is
The Nipro SafeTouch Safety Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It features a safety mechanism to prevent needlestick injuries, enhancing safety for healthcare providers. The needle is typically used in conjunction with dialysis machines to facilitate the removal and return of blood during treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is essential for patients with chronic kidney disease requiring regular hemodialysis. The needle's safety features make it particularly useful in high-volume settings where multiple patients are treated daily, reducing the risk of needlestick injuries.
Indications for Use
The Nipro SafeTouch Safety Fistula Needle is indicated for use in patients requiring vascular access for hemodialysis. It is suitable for patients with arteriovenous fistulas, a common access point for dialysis treatment.
Practical Considerations
The needle is available in various gauges and lengths to accommodate different patient needs and fistula sizes. It is compatible with standard dialysis equipment. Proper technique is essential to ensure effective and safe use, including securing the needle to prevent dislodgement during dialysis.
Frequently Asked Questions
What is the Nipro SafeTouch Safety Fistula Needle used for?
It is used for vascular access in patients undergoing hemodialysis, specifically to access arteriovenous fistulas.
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 vascular access for hemodialysis, particularly those with arteriovenous fistulas.
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.