Description

The SmartSite™ VialShield Closed Vial Access Device by BD is an innovative solution designed for healthcare professionals seeking safe and efficient access to medication vials. This device offers a needle-free, mechanically and microbiologically closed system, ideal for use in hospitals, healthcare facilities, and pharmacies.

Key Features

• Needle-Free Access: Enhances safety by reducing the risk of needlestick injuries.
• SmartSite™ Valve: Provides secure Luer access for seamless fluid transfer.
• Dual Lumen Spike: Facilitates fluid transfer and vented air, ensuring efficient medication reconstitution or dispensing.
• Locking Shroud: Equipped with retention tabs for secure attachment to vial tops.

Advanced Protection

The device is engineered to trap vapors and reduce surface contamination, offering protection from exposure to hazardous drugs such as chemotherapy agents. Its hydrophobic filter membrane, made from PTFE and Polyester, prevents particulates and contaminants while allowing pressure equalization and preventing liquid escape.

Sterility and Compatibility

• Sterile Fluid Path: Ensures medication sterility is maintained for up to 7 days in a USP <797> compliant environment.
• Size Variability: Available in three sizes (13 mm, 20 mm, and 28 mm) to fit various vial sizes, enhancing versatility.

Material Composition

Constructed with high-quality materials including polycarbonate housings, silicone check valves, and polyether polyurethane barrier film. The device does not contain natural rubber latex, minimizing allergy risks.

Regulatory Compliance

• FDA Clearance: Cleared under 510(k) K132863.
• Health Canada Registration: Ensures adherence to stringent healthcare standards.
• Biocompatibility Testing: Compliant with ISO 10993-1 standards, ensuring safety and reliability.

Packaging Details

Each case contains 50 units, with dimensions of 23 in x 10 in x 10 in and a weight of 2.15 lb. The molded polyethylene cap included in the packaging adds an extra layer of protection.

The SmartSite™ VialShield Closed Vial Access Device is a crucial tool for healthcare settings, substantially equivalent to the SmartSite® Vented Vial Access Device, providing a robust solution for medication management and healthcare worker safety.