Braebon Medical Corp.

Braebon Medical Corp. specializes in respiratory and monitoring devices. Their portfolio includes single-use gas-sampling/monitoring respiratory tubing like nasal and oro-nasal cannulas with built-in filters, reusable electrical connection cables, polysomnographs (sleep study equipment), pneumographs (chest movement monitors), electrocardiographic lead sets, and air/gas pressure transducers. They also produce mandible-repositioning orthoses for sleep-disordered breathing and reusable temperature probes. These devices are designed for respiratory care, sleep diagnostics, and patient monitoring.

Braebon Medical Corp. is based in the United States. Their devices are regulated under FDA classifications, specifically Class I and Class II, depending on the product’s risk level. Since the company operates in the US, its devices fall under US regulatory frameworks, including submissions recorded in the FDA 510(k) and Unique Device Identifier (UDI) registries.

Braebon Medical Corp.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track submissions for medical devices to ensure compliance with US regulatory requirements. The 510(k) process is used for devices deemed substantially equivalent to existing approved products, while the UDI system helps identify devices throughout their lifecycle.

Braebon Medical Corp.’s devices are classified under FDA’s risk-based system as either Class I or Class II. Class I devices generally pose minimal risk and may require only general controls, such as good manufacturing practices. Class II devices involve a higher level of risk and require special controls beyond general controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and complexity, as outlined in the FDA’s regulatory framework.

Braebon Medical Corp. manufactures both single-use and reusable devices. Single-use items include gas-sampling/monitoring respiratory tubing like nasal cannulas with filters (e.g., *ValueFlow Nasal Cannula + Filter*), which are designed for one-time use to prevent cross-contamination. Reusable devices in their portfolio include electrical connection cables (e.g., *BRAEBON 1 mm Dual Safety Pin to 2.5 mm Male Phone Connector Cable*), electrocardiographic lead sets, pneumographs, and temperature probes, which are built for durability and repeated use with proper sterilization or maintenance.