Description

The Kangaroo™ Gastroenterology Feeding Tube is a specialized medical device crafted by Covidien, designed to meet the unique nutritional needs of neonatal and pediatric patients. This sterile, disposable tube is intended for those who require enteral feeding due to challenges in obtaining nutrition by mouth or difficulties in chewing or swallowing safely. Available by prescription only, it ensures safe and effective delivery of nutrition, liquids, or medication.

Material and Design

• Material: Made from high-quality Polyurethane (PU), the feeding tube offers durability and flexibility, essential for delicate medical applications.
• Design: Features a single lumen design, enhancing simplicity and reliability in use.

Connector Specifications

• ENFit Connector: Equipped with a male ENFit small bore connector at the proximal end, specifically designed to prevent misconnections. This aligns with ISO 80369-3 standards, ensuring compatibility and safety in enteral applications.
• Compatibility: Intended for use with enteral feeding syringes or feeding sets designed for such applications, providing a seamless integration into existing medical setups.

Safety and Compliance

The Kangaroo™ Feeding Tube undergoes rigorous testing to comply with international standards, including ISO 80369-3 and ISO 80369-20. Key safety features and tests include:

• Fluid Leakage Prevention
• Stress Cracking Resistance
• Tensile Strength
• Connector Security: Resistance to separation from axial load, unscrewing, and overriding, minimizing the risk of disconnection.

Performance Evaluation

Flow testing has demonstrated performance substantially equivalent to existing predicate devices. The ENFit connector's tensile strength and risk of misconnection have been thoroughly assessed through risk management and human factors validation studies. These evaluations ensure that the device meets high safety and functional performance standards without requiring clinical evaluations.

Conclusion

With no significant differences affecting safety or effectiveness compared to predicate devices, the Kangaroo™ Gastroenterology Feeding Tube stands as a reliable and trusted solution for healthcare providers. Its thoughtful design and comprehensive compliance with safety standards make it an essential tool in the management of enteral feeding for vulnerable patient populations.