Description

The CODAN Empty Sterile Bag is a specialized single-use medical device designed for healthcare professionals in the management of intravenous (IV) solutions. Its primary function is to facilitate the safe admixture, storage, and delivery of IV solutions, ensuring sterility and reliability throughout its use.

Key Features

• Medication Port: Depending on the bag type, it includes a resealable or needle-free medication port, allowing for the secure addition of medications.
• Fleboflex Outlet Port: Equipped with an internal membrane, this port ensures integrity and provides a secure connection to administration sets.
• ISO 15747 Compliance: Designed and tested according to international standards for plastic containers used in intravenous injections.

Packaging and Design

The bag comes with an overwrap that acts as a moisture barrier. It's normal for condensation to appear inside the overwrap, which does not compromise the bag's safety or functionality. The steam sterilization process may cause horizontal marks and some opacity, but these factors do not affect the bag's efficacy or performance.

Primary Packaging

• Made from PVC-free thermoformed multilayer films, providing a sterile barrier system.
• Features a soft, fibre-free peel with tear flaps for easy, aseptic opening.
• High transparency and good puncture resistance.
• Complies with EN ISO 11607 and EN 62366-1 standards.

Secondary/Tertiary Packaging

• Constructed from FSC- or PEFC-certified cardboard with high recycled content.
• All packaging materials are recyclable, aligning with Directive 94/62/EEC on Packaging and Packaging Waste.

Environmental Considerations

The packaging is designed to minimize environmental impact, being free from phthalates, nanomaterials, and other potentially harmful substances. It does not contain substances of very high concern (SVHC) above 0.1%, ensuring safety and compliance with EU medical device regulations.

Manufacturer and Distributor

Manufactured by Laboratorios Grifols, S.A., and distributed by CODAN US Corporation, this product embodies a commitment to quality and environmental responsibility, making it a trusted choice in medical settings.