Linde’s new NOxBox I Plus delivers NOxivent (nitric oxide) gas with targeted enhancements over the NOxBoxi delivery system.

RT’s Three Key Takeaways

  1. Linde Gas & Equipment Inc has submitted a 510(k) premarket notification to the FDA for its NOxBox I Plus, a nitric oxide delivery and monitoring system.
  2. The NOxBox I Plus delivers NOxivent (nitric oxide) gas to improve oxygenation and reduce ECMO need in neonates with hypoxic respiratory failure and pulmonary hypertension.
  3. Enhancements include streamlined setup, improved ergonomics, precise controls, and better ventilator compatibility for an enhanced user experience.


Linde Gas & Equipment Inc has submitted a 510(k) premarket notification application with the US FDA for its nitric oxide delivery and monitoring system, NOxBox I Plus. The NOxBox I Plus delivers the company’s NOxivent (nitric oxide) gas, for inhalation. 

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.

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.

“This FDA submission builds on the success of our innovative NOxBoxi delivery system,” said Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment Inc. “We look forward to [the] NOxBox I Plus 510(k) clearance, and we remain steadfast in our commitment to nitric oxide therapy and continuous improvement in our technology.”

The NOxBoxi delivery system has been in commercial use in 40+ countries since 2013 and in the US since October 2018. Currently, in the US, the NOxBoxi delivery system is being used in hundreds of locations.


Manufacturer Note

The NOxBoxi Nitric Oxide Delivery System 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 prior to use.  Important safety information and full prescribing information can be found at www.noxiventUS.com.