Nasal Cannulas and Oxygen Masks

Form: Nasal cannulas: Deliver low-flow oxygen via prongs inserted into nostrils, Oxygen masks: Cover nose and mouth for higher flow rates

Strength: Nasal cannulas typically deliver 1-6 L/min; masks provide 6-15 L/min, available in various sizes and materials

Reference Brands: Puritan Bennett, Salem Silk, Hartmann, Linde

Category: Medical Devices

Nasal cannulas and oxygen masks are regulated in both the EU and US, with dossiers demonstrating safety, material biocompatibility, and performance in compliance with GMP and MDR standards. In the US, FDA approval involves validation, safety testing, and certification, while in the EU, CE marking certifies conformity with medical device regulations. These devices undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, reliable oxygen delivery devices essential for effective respiratory support in healthcare and veterinary applications worldwide.