BOMImed Inc

BOMImed Inc specializes in single-use airway management and respiratory support devices. Their portfolio includes laryngoscope blades (like the FEATHER-FLEX), breathing circuit bags, and endotracheal tube introducers (such as the INTROES POCKET BOUGIE). Additionally, they produce reusable heat/moisture exchangers and microbial medical gas filters, like the AQUESURE FILTER HUMIDIFIER, which are used to humidify and filter gases in respiratory therapy.

BOMImed Inc is based in the United States, meaning its devices must comply with U.S. regulatory standards, including those set by the FDA. Since the company’s products fall under Class I and Class II classifications, they are subject to FDA oversight, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and regulatory transparency.

BOMImed Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking medical devices in the U.S., ensuring transparency in their classification (Class I or Class II) and compliance with FDA requirements. The UDI system helps healthcare providers and regulators verify device details, including manufacturer information and regulatory status.

BOMImed Inc’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product, ensuring appropriate scrutiny based on potential patient impact.