CUTTING EDGE HC BRANDS LLC

Cutting Edge HC Brands LLC specializes in respiratory and feeding devices. Their portfolio includes single-use and reusable products like gastrostomy tubes for nutritional support, secretion suction kits for clearing airways, and breathing circuit connectors for ventilators. They also produce oxygen administration tubing, suction catheters, suction/irrigation tubing, inhaler spacers, and heat/moisture exchangers to maintain airway moisture during ventilation. These devices are designed for clinical use in patient care settings.

The company is based in the United States. As a U.S.-based manufacturer, their devices are subject to U.S. medical device regulations, including compliance with FDA requirements for safety, performance, and quality.

Devices produced by Cutting Edge HC Brands LLC are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices by assigning a unique identifier to each product, ensuring transparency and traceability in the healthcare system.

The company’s devices fall into two primary classification categories under FDA regulations: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and benefits.