Southmedic Incorporated

Southmedic Incorporated manufactures single-use and reusable medical devices, including vortex oxygen face masks like the OxyPlus™ and OxyMask™, disposable items such as face splash shields and scalpel blades, reusable surgical instrument cleaning brushes and endoscope cleaning utensils, breathing circuit gas-sampling and monitoring sets like the Capnoxygen®, and medical device cleaning agents.

Southmedic Incorporated is based in the United States, as indicated by the COUNTRY field in the device data, and operates under the regulatory requirements applicable to medical devices in that jurisdiction.

Southmedic Incorporated's devices are listed in the FDA's Unique Device Identifier (UDI) database, as specified in the LISTED IN field, which confirms their inclusion in the UDI system for device traceability and identification.

Southmedic Incorporated's devices are classified under FDA categories including Class I, Class II, and Class III, as stated in the DEVICE CLASSES field, reflecting a range of risk-based classifications across their product portfolio.