Device Recall INOmax DS (Delivery System)

Serial 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Anesthesiology Devices

2

No

Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.

INOmax DS (Delivery System) Model 10003 & 10007. || The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.