COASTAL LIFE SYSTEMS, INC.

Coastal Life Systems, Inc. specializes in two primary device types: single-use endoscopic insufflation tubing sets, which are used to deliver gas during endoscopic procedures, and vascular irrigation cannulas specifically designed for cardiac vessel graft applications. These devices are engineered for surgical and interventional environments where controlled fluid or gas delivery is critical.

Coastal Life Systems, Inc. is based in the United States, which means its devices must comply with FDA regulations. The company’s products are classified under FDA’s Class I and Class II categories, reflecting varying levels of risk and regulatory oversight. Since the devices are manufactured domestically, they fall under the U.S. regulatory framework for medical devices, ensuring alignment with FDA requirements.

Coastal Life Systems, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices, ensuring traceability and transparency in the regulatory and clinical settings. This listing helps healthcare providers and regulators verify the identity of the devices in use.

Coastal Life Systems, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may 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 device type.