{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QTB",
      "openfda": {
        "pma_number": [
          "P200044"
        ],
        "registration_number": [
          "8020864",
          "3020846279",
          "2133772"
        ],
        "fei_number": [
          "3000209794",
          "3005737257",
          "3020846279"
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      },
      "review_panel": "AN",
      "medical_specialty": "",
      "device_name": "Nitric Oxide Generator And Delivery System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "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).",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}