The BDR-19™ has received Emergency Use Authorization
The BreathDirect™ BDR-19™ is produced by a highly-skilled team with long-term expertise in medical product development, manufacturing and regulatory processes. The BDR-19 was conceived and designed by Nectar Product Development in Long Beach, CA, sourced by Hubbell, Inc. in Shelton, CT, and is being manufactured by Evolve Manufacturing Technologies, Inc. in Fremont, CA.
Nectar is a product development company in Long Beach, California, specializing in developing integrated products across multiple sectors in the medical, laboratory, and scientific fields. Nectar’s team of designers, engineers, and product management experts have built a record of delivering consistent successes by melding proven, user-centered design methodologies with the creativity to think outside the box to produce breakthrough medical products. Nectar is certified as an ISO 13485 Certified Quality Management System facility, adhering to the highest levels of quality control to produce systems that operate optimally and ensure patient safety.
EVOLVE MANUFACTURING TECHNOLOGIES, INC.
Evolve Manufacturing Technologies, located in the heart of Silicon Valley, specializes in medical contract manufacturing. It offers innovative end-to-end services for new product introduction, manufacturing, postproduction and supply chain management. Evolve’s 75,000 square foot, state-of-the-art facility carries FDA, ISO 9001 Quality Management, and ISO 13485 Medical Devices Quality Management certifications, as well as ISO 14644:2015 certified Class 7 & Class 8 Cleanrooms. Evolve produces ultrasound, MRI, X-ray, and surgical robotic systems, and is now on the front lines combatting COVID-19, producing vital testing kits and the new, BreathDirect™ BDR-19 ventilator.
Hubbell, Inc. is an acclaimed manufacturer of electrical and electronic products for commercial, industrial, utility, and telecommunications markets. Founded in 1880, the company has unified premium brands to become a cohesive, global powerhouse – delivering innovative, high quality and dependable electrical, power and lighting products and solutions to industry. For BreathDirect, Hubbell has established the reliable and consistent supply chain of U.S. parts necessary to effectively fulfill our manufacturing needs.