Description

The SmartSite® VialShield Closed Vial Access Device is an essential tool for healthcare professionals, offering a secure and sterile method for accessing medications stored in vials. Designed specifically for use in hospitals, healthcare facilities, and pharmacies, it is particularly suited for handling sensitive medications such as chemotherapy agents.

Key Features

• Needle-Free Access: Utilizes a SmartSite® valve to provide needle-free access, enhancing safety and reducing the risk of needlestick injuries.
• Dual Lumen Spike: Facilitates efficient fluid transfer and pressure equalization, ensuring smooth operation.
• Locking Shroud: Equipped with retention tabs for secure attachment to vials, preventing accidental dislodgement.

Contamination Prevention

The device is equipped with a hydrophobic filter membrane that serves multiple functions:

• Prevents particulate and contaminant ingress.
• Prevents liquid escape during misuse.
• Allows air pressure equalization.

Material and Compatibility

• Materials: Constructed from high-quality materials including polycarbonate, silicone, and PTFE, ensuring durability and reliability.
• Compatibility: Designed for use with 20 mm vials and made without DEHP or natural rubber latex, enhancing safety for a wide range of applications.

Biocompatibility and Safety

• Compliance: Meets ISO 10993-1 biocompatibility standards.
• Vapor Retention: Effectively retains vapors from medications, maintaining the integrity of the vial contents.
• Sterility Maintenance: Keeps vial medications sterile for up to 7 days in a USP <797> compliant environment.

Physical Specifications

• Length: Approximately 6.35 cm (2.5 in).
• Priming Volume: 0.1 mL.

Regulatory Information

• Prescription Use: Complies with 21 CFR 801 Subpart D regulations.
• Registration: Registered with Health Canada.

Packaging

Each case contains 50 units, providing ample supply for healthcare settings. This device is a reliable and effective solution for maintaining medication sterility and safety, crucial for any healthcare environment.