{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Novalung control panel",
        "Novalung pump drive DP3",
        "XLung kit",
        "Novalung console",
        "IPS Pressure Sensor connecting cable",
        "Novalung battery pack",
        "Novalung sensor box",
        "Infusion Stand compact",
        "Trolley N",
        "Novalung System",
        "Compact holder",
        "Support for backup pump drive",
        "Novalung power supply",
        "Flow Sensor 3/8x3/32"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3002845651",
        "fei_number": "3002845651",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "XENIOS AG",
        "address_line_1": "Obere Steinfurt 8-10",
        "address_line_2": "",
        "city": "Stolberg North Rhine-Westphalia",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "52222",
        "us_agent": {
          "name": "Laura Reed",
          "business_name": "Fresenius Medical Care North America",
          "bus_phone_area_code": "781",
          "bus_phone_num": "4917581",
          "bus_phone_extn": "",
          "fax_area_code": "781",
          "fax_num": "6999635",
          "email_address": "Laura.Reed@freseniusmedicalcare.com",
          "address_line_1": "920 Winter Street",
          "address_line_2": "",
          "city": "Waltham",
          "state_code": "MA",
          "iso_country_code": "US",
          "zip_code": "02451",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Xenios AG",
          "owner_operator_number": "10045964",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Im Zukunftspark 1",
            "address_2": "",
            "city": "Heilbronn",
            "state_code": "DE-BW",
            "state_province": "Baden-Wurttemberg",
            "iso_country_code": "DE",
            "postal_code": "74076"
          }
        }
      },
      "pma_number": "",
      "k_number": "K191407",
      "products": [
        {
          "product_code": "QJZ",
          "created_date": "2020-03-10",
          "owner_operator_number": "10045964",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K191407"
            ],
            "device_name": "Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.4100",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}