Advanced Concept Innovations, LLC

Advanced Concept Innovations, LLC specializes in surgical and medical respirators that are designed for single-use applications. These devices are specifically intended for patient ventilation during surgical procedures, providing controlled breathing support in operating room environments. The company’s focus is on non-antimicrobial respirators, ensuring they meet clinical needs without antimicrobial coatings.

Advanced Concept Innovations, LLC is based in the United States. While the company’s devices are manufactured domestically, their intended use is within the U.S. market, adhering to regulatory standards and compliance requirements applicable there. The design and classification of these devices align with FDA guidelines for medical devices.

The respirators produced by Advanced Concept Innovations, LLC fall under FDA Class II classification. This classification is determined by the U.S. Food and Drug Administration based on factors like the device’s risk level, intended use, and potential health impact. Class II devices typically require special controls in addition to general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, the devices manufactured by Advanced Concept Innovations, LLC are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in regulatory compliance. Listing in this database helps healthcare providers and regulators verify the identity of the device and its manufacturer.