Telesair, Inc

Telesair, Inc. specializes in manual professional high-flow respiratory units that include built-in humidification. Their product line also covers disposable components like expiratory filters, water traps, nasal cannulas (in small, medium, and large sizes), heated breathing sets, and water chamber adapters. These devices are designed to support respiratory care by delivering humidified oxygen and filtration, making them suitable for various clinical settings.

Telesair, Inc. is headquartered in the United States. Its devices are listed in multiple regulatory databases, including the EU’s eudamed registry, the FDA’s 510(k) clearance system, and the FDA’s UDI (Unique Device Identification) listings. These registries reflect the company’s compliance with global medical device regulations.

Telesair, Inc.’s devices fall under Class II and Class IIa classifications. Class II devices typically require special controls to ensure their safety and effectiveness, while Class IIa devices are a subset with slightly lower risk but still require regulatory oversight. These classifications help determine the regulatory scrutiny and documentation requirements for each product.

Yes, Telesair, Inc.’s devices are designed for non-invasive ventilation and respiratory care across various settings, including hospitals, clinics, and home care environments. The high-flow respiratory units and accessories are intended to provide portable, humidified oxygen delivery, making them versatile for acute and chronic respiratory support scenarios.