{
  "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": {
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      "third_party_flag": "N",
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      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QLN",
      "openfda": {},
      "review_panel": "CV",
      "medical_specialty": "",
      "device_name": "Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19",
      "review_code": "",
      "unclassified_reason": "11",
      "medical_specialty_description": "Unknown",
      "device_class": "N",
      "definition": "to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.",
      "regulation_number": "",
      "implant_flag": "N",
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}