Description

The CODAN Empty Sterile Bag is a specialized medical device designed for healthcare professionals requiring reliable solutions for intravenous (IV) preparations. With a capacity of 150 mL, this single-use, sterile bag is crafted to meet the demanding needs of medical environments, ensuring safe admixture, storage, and delivery of IV solutions.

Key Features

• Dual EVA Ports: Equipped with two EVA ports, the bag facilitates versatile and secure connections, enhancing its functionality in various medical settings.
• High-Quality Material: Constructed from PVC-free and DEHP-free materials, it eliminates the presence of phthalates and other potentially harmful substances, aligning with stringent healthcare standards.

Packaging and Sterility

The primary packaging utilizes thermoformed multilayer films, primarily PE-based Formpeel®-T³ film, providing high transparency and puncture resistance. This ensures the integrity and sterility of the bag, which is maintained up to three years post-manufacture. The packaging is designed for easy, aseptic opening, crucial for maintaining sterility in clinical environments.

Environmental Commitment

CODAN’s commitment to environmental sustainability is evident in the packaging design. The secondary and tertiary packaging comprises FSC- or PEFC-certified cardboard, mostly made from 100% recycled paper, and recyclable LD-PE bags. Compliance with Directive 94/62/EEC on Packaging and Packaging Waste underscores its environmentally responsible approach.

Regulatory Compliance

The product adheres to several regulatory standards, including:

• EN ISO 11607
• Council Directive 93/42/EEC (MDD)
• EN ISO 13485
• EU 2017/745 (MDR)

These certifications assure healthcare providers of the product’s quality and reliability.

Availability

Available exclusively to licensed healthcare professionals, the CODAN Empty Sterile Bag is a trusted choice for medical institutions seeking dependable IV solution management. Its design and compliance with medical device regulations make it an essential component in healthcare settings, supporting safe and effective patient care.