{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QNR",
      "openfda": {
        "k_number": [
          "K230364",
          "K234118",
          "K233736",
          "K222038",
          "K223898",
          "K202751",
          "K211830",
          "K250199"
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        "registration_number": [
          "9617601",
          "3011468686",
          "2916596",
          "1218444",
          "3010163695",
          "9611665",
          "2133810",
          "3004593495",
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      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Blood Pump For Ecmo, Long-Term (> 6 Hours) Use",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.",
      "regulation_number": "870.4100",
      "implant_flag": "N",
      "submission_type_id": "1"
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}