GHC HEALTHCARE, INC.

GHC Healthcare, Inc. specializes in single-use medical devices primarily for airway management, such as basic endotracheal tubes and airway suction catheters. Their product line also includes intravenous administration sets, nebulizing system delivery sets, indwelling urethral catheterization kits for adults, surgical gowns, and nasal oxygen cannulas designed for carbon-dioxide sampling. These devices are developed to support critical care, respiratory therapy, and general patient care procedures.

GHC Healthcare, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s risk-based system. The FDA categorizes these devices as Class II, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

Yes, GHC Healthcare, Inc.’s devices are recorded in the FDA’s Unique Device Identification (UDI) database. This registry is critical because it provides a standardized way to track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain, improving patient safety, and facilitating regulatory compliance. The UDI system helps healthcare providers and regulators quickly identify and verify device information.

All of GHC Healthcare, Inc.’s listed devices fall under FDA Class II classification. This classification indicates that the devices are not low-risk (like Class I) but also not high-risk (like Class III). As a result, they require additional regulatory controls beyond general good manufacturing practices, such as performance standards, post-market surveillance, or labeling requirements, to ensure their safety and effectiveness for intended use.