definiens: shall mean the business of the development, manufacture, commercialization, promotion, sale, import, export, servicing, repair, training, storage, distribution, transportation, licensing, or other handling or disposition of any product orservice ( including any product or service that utilizes, contains, or includes nitric oxide forinhalation, a device intended to deliver nitric oxide, or a service that delivers or supportsthe delivery of nitric oxide ), bundled or unbundled, for or used in connection with ( a ) thediagnosis, prevention, or treatment, in both adult and/or pediatric populations, and whetherin or out patient, of : ( i ) hypoxic respiratory failure associated with pulmonary hypertension,(ii ) pulmonary hypertensive episodes and right heart failure associated with cardiovascularsurgery, ( iii ) bronchopulmonary dysplasia, ( iv ) the management of ventilation — perfusionmismatch in acute lung injury, ( v ) the management of ventilation — perfusion mismatch inacute respiratory distress syndrome, ( vi ) the management of pulmonary hypertensionepisodes and right heart failure in congestive heart failure, ( vii ) pulmonary edema from highaltitude sickness, ( viii ) the management of pulmonary hypertension episodes and rightheart failure in pulmonary or cardiac surgery, ( ix ) the management of pulmonaryhypertension episodes and right heart failure in organ transplant, ( x ) sickle cell vaso - occlusive crisis, ( xi ) hypoxia associated with pneumonia, or ( xii ) ischemia - reperfusioninjury ; or ( b ) the use of nitric oxide to treat or prevent conditions that are primarily managedin the hospital