GLOBAL TRANSPLANT SOLUTIONS, INC.

Global Transplant Solutions, Inc. specializes in perfusion sets used for kidney donor-organ preservation and transport. These devices are designed to maintain organ viability during transit to transplantation centers, helping ensure the organs remain suitable for successful grafting. The primary focus is on preserving organs in optimal conditions before they reach the surgical site.

The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and listing of its medical devices.

Global Transplant Solutions, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability in the supply chain.

The company’s devices, such as perfusion sets for kidney organ preservation, are classified as Class II medical devices. This classification is based on their intended use and the level of risk they pose, requiring special controls beyond general good manufacturing practices to ensure safety and effectiveness.