Description

The EQUASHIELD Vial Adaptor is an integral component of the EQUASHIELD Closed System Drug Transfer Device (CSTD), engineered to ensure safe and contamination-free access to drug vials. This adaptor is specifically designed for healthcare environments where the handling of hazardous drugs, such as antineoplastic agents, requires the utmost precision and safety.

Key Features

• Leak-Proof Barrier: The adaptor securely snaps onto standard vials, creating a closed, leak-proof barrier. This design effectively prevents environmental contaminants from entering the system and stops drug vapors or aerosols from escaping.

• Compatibility: Available in three vial neck sizes—13mm, 20mm, and 28mm—with the 20mm version accommodating concave vial stoppers.

• Material Safety: Constructed from ABS housing, polypropylene protective cap, and polyisoprene membrane. It is DEHP-free, latex-free, and BPA-free, ensuring compatibility with various medical standards.

Design and Safety

• Single-Use and Sterile: The adaptor is single-use, nontoxic, non-pyrogenic, and provided sterile, maintaining integrity as long as the packaging remains intact.

• Double Membrane: Features a double membrane for enhanced leak-proof performance and integrated closed system pressure equalization.

• Needle Stick Safe Design: Eliminates the need for priming and insertion tubes, and is not a gravity feed system. Allows up to 10 reconnections and prevents microbial ingress for up to 7 days.

Specifications

• Dimensions: 48 x 31 mm with a 23 mm distal end and a priming volume of 0.05 ml.

• Sterilization: EO/SA/IL 10⁻⁶.

Regulatory Compliance

• Medical Device Classification: Class II medical device compliant with 21 CFR 880.5440.

• FDA Clearance: Holds FDA 510(k) clearance (K132899) and complies with multiple ISO standards for medical devices and sharps safety.

• USP Class IV Compliant.

Packaging

Supplied with a protective cap, the adaptor is available in packaging options of 120 or 240 units per box, with corresponding master case quantities.

Intended Use

Designed for licensed pharmacists and healthcare professionals in hospitals and clinics, the EQUASHIELD Vial Adaptor facilitates the safe handling of hazardous drugs, minimizing exposure to drug vapors, aerosols, and spills. It is particularly suited for chemotherapy drug compounding and administration, as well as the preparation and reconstitution of hazardous drugs in clinical settings.