Description

The SHARP AVF Needle is a specialized medical device designed to provide reliable vascular access for hemodialysis treatment. Its ultra-sharp, siliconized 3-bevel needle ensures smooth and precise puncture, enhancing the ease of cannulation. The ultra-thin wall design allows for optimal blood flow, while the oval-shaped back-eye minimizes vessel wall aspiration, contributing to efficient dialysis sessions.

Key Features

• Needle Design: The needle's large diameter supports high blood flow, and its sharp pointed tip facilitates easy entry into the fistula. Optional extra holes or grooves are available to improve blood flow and reduce clotting.
• Bevel Position Indicators: Black and red dots indicate the bevel position, aiding in accurate needle placement.
• Wings and Clamps: The device features turnable or fixed, textured, color-coded wings for secure grip and easy gauge size recognition. A color-coded occlusion clamp helps distinguish between arterial and venous needles.
• Connection: The tapered luer provides safe and easy connection with bloodlines, while the soft, flexible tubing reduces needle movement and eases clamping.

Safety Features

A protective shield with a white locking mechanism helps prevent accidental needlesticks by sliding forward to lock the wings in place. This single-use, sterile device is made from medical-grade stainless steel and is free from latex, BPA, and DEHP.

Sterilization and Biocompatibility

The SHARP AVF Needle undergoes gamma sterilization and ultrasonic cleaning to ensure a contaminant-free, smooth surface. It complies with ISO 10993 standards, offering high corrosion resistance and biocompatibility, thereby reducing the risk of vascular access complications.

Quality and Performance

The needle is rigorously tested for flow rate, leakage, particulate contamination, and tensile strength. Quality control inspections are conducted at each manufacturing stage, including magnified inspections of needle tips and holes. The product meets international standards such as ISO 7864, ISO 9001:2015, ISO 13485, and ASTM F3014-14.

Configurations

Available in gauge sizes 14G, 15G, 16G, and 17G, with needle lengths ranging from 20 mm to 38 mm. Tube lengths are offered in 150 mm and 300 mm. The needle can be configured as arterial, venous, or combined, with options for turnable or fixed wings. Packaging includes single-pack or 2-pack options, in sterile PP bags.

Intended Use

The SHARP AVF Needle is intended for vein puncture during hemodialysis, typically used in pairs to draw and return blood. Its design enhances patient safety and mobility, making it a reliable choice for healthcare providers in dialysis settings.