DANBURY, Conn., February 13, 2025 – Linde Gas & Equipment Inc. announced today the submission of a 510(k) premarket notification application with the U.S. Food and Drug Administration (FDA) for NOXBOX^® I PLUS, a nitric oxide delivery and monitoring system for NOXIVENT^® (nitric oxide) gas, for inhalation.  

“This FDA submission builds on the success of our innovative NOxBOX^®_i delivery system,” said Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment Inc. “With the addition of the NOXBOX^® I PLUS, we are committed to providing healthcare professionals with an enhanced system that offers an economical and reliable way to deliver inhaled nitric oxide therapy.”

Linde has made targeted enhancements to the delivery system’s functionality including a streamlined setup process, ergonomic refinements, precise controls, and further compatibility with various ventilators allowing for an enhanced user experience “We look forward to NOXBOX I PLUS’ 510(k) clearance, and we remain steadfast in our commitment to nitric oxide therapy and continuous improvement in our technology,” said Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment Inc.

Linde’s NOXIVENT (nitric oxide) gas, for inhalation is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. 

The NOxBOX^®_i delivery system has been in commercial use in 40+ countries since 2013 and in the U.S. since October 2018.  Currently, in the U.S., the NOxBOX^®_i delivery system is being used in hundreds of locations.

→ Contraindication:  NOXIVENT is contraindicated in neonates dependent on right-to-left shunting of blood.  

→ Rebound:  Abrupt discontinuation of NOXIVENT may lead to worsening oxygenation and increasing pulmonary artery pressure

The NOxBOX_i delivery system and NOXIVENT (nitric oxide) gas, for inhalation must only be used in accordance with the indications, contraindications, warnings, precautions, and other information and conditions of use described in the nitric oxide drug prescribing information and labeling (currently neonates).  Refer to this material before use.  Important safety information and full prescribing information can be found at www.noxiventus.com. 

About Linde Gas & Equipment Inc.  

Linde Gas & Equipment Inc. is a leading provider of medical gases and associated therapies.  Hospitals, clinics, nursing homes and other healthcare facilities trust Linde to provide medical gases like nitrogen for preservation, helium for MRIs, and oxygen and respiratory therapy gases to help patients breathe. Linde offers a full line of pure medical gases in high-pressure cylinders under our Medipure™ trademark, your assurance of quality and purity.

In an industry that touches all our lives, we know our customers expect the highest quality medical gases and equipment and the most comprehensive service — and that’s what we deliver. We are a single reliable source for medical and specialty gases, equipment and services. Our distribution network is one of the largest in the United States — and we are committed to innovation that helps you stay one step ahead. 

Please visit: www.lindedirect.com/solutions/healthcare-solution

Media Contact:

Michael Chiappetta

+1 203 837 2204

mike.chiappetta@linde.com