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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nitric oxide generator and delivery system
Definition The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2).
Product CodeQTB
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 2 4 1 3 0

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 1 1
Gas Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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