Description

The AGANI™ Safety Needle is meticulously designed to enhance safety and efficiency in medical settings. This sterile, single-use hypodermic needle features an integrated safety mechanism aimed at minimizing the risk of accidental needle stick injuries, a crucial consideration for healthcare professionals.

Key Features

• Integrated Safety Shield: The needle is equipped with a safety shield that can be activated with one hand immediately after use. This feature provides audible feedback and a clear sheath window for activation confirmation, ensuring reliable protection.

• Versatile Activation: The safety shield can be engaged by pressing against a hard surface, using a finger, or with a thumb, offering flexibility and ease of use in various clinical environments.

Compatibility and Design

• Syringe Compatibility: Designed to fit standard Luer Slip and Luer Lock syringes, the AGANI™ Safety Needle offers broad compatibility.

• Needle Geometry: The sharp lancet point with specialized geometry facilitates easier skin penetration, reducing trauma. Select models feature a steeper point angle to lower the risk of vascular perforation.

• Material and Coating: Constructed from silicone-coated stainless steel, the needle ensures smooth insertion and reduced patient discomfort. Its thin-walled design enhances flow rate efficiency.

Identification and Recognition

• Colour-Coded Hub: The ISO 6009 colour-coded polypropylene hub allows for easy gauge identification, while the semi-transparent hub aids in flashback recognition.

Material Specifications

• Construction Materials: The needle components, including sheath, collar, hub, and protector, are made from polypropylene. It contains no PVC or natural rubber latex, reducing allergy risks.

• Sterilization: Sterilized using ethylene oxide (EO) to a Sterility Assurance Level of at least 10⁻⁶, ensuring high standards of hygiene.

Product Longevity

• Shelf Life: The needle boasts a 5-year shelf life, with batch number and expiry date clearly printed on the blister package.

Regulatory Compliance

• Certifications: CE certified as a Class IIa medical device, it complies with European Directive 2010/32/EU for sharps injury prevention.

Manufacturer Information

• Manufacturing: Produced by Zhejiang Kindly Medical Devices Co. Ltd. in China, with distribution and regulatory representation in Europe, sometimes referenced as Terumo.

Size and Packaging Options

• Available Sizes: Offered in gauges ranging from 18G to 30G and lengths from 13 mm to 50 mm, with both regular and short bevel options.

• Packaging: Each needle is individually packed in a sterile blister pack, with unit boxes containing 100 needles. Shipping cartons vary by item code.

Handling Instructions

• Single Use: Intended for single use only. Do not reuse or use if the package is damaged.

• Disposal: Dispose of immediately after use according to local safety standards. Not autoclavable.

• Storage: Store away from extreme temperatures and humidity to maintain integrity.

The AGANI™ Safety Needle represents a commitment to safety, precision, and quality, making it an essential tool for healthcare providers worldwide.