{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "proprietary_name": [
        "CARPEDIEM System"
      ],
      "establishment_type": [
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3043804021",
        "fei_number": "3043804021",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Mozarc Medical Italy",
        "address_line_1": "Via Statale Sud N 153/A",
        "address_line_2": "",
        "city": "Mirandola Modena",
        "state_code": "",
        "iso_country_code": "IT",
        "zip_code": "",
        "postal_code": "41037",
        "us_agent": {
          "name": "Carol Ming",
          "business_name": "MOZARC MEDICAL US LLC",
          "bus_phone_area_code": "774",
          "bus_phone_num": "2910767",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "fdafurlssiteaccess@mozarcmedical.com",
          "address_line_1": "15 Hampshire St",
          "address_line_2": "",
          "city": "Mansfield",
          "state_code": "MA",
          "iso_country_code": "US",
          "zip_code": "02048",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Mozarc Medical US LLC",
          "owner_operator_number": "10090982",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "15 Hampshire Street",
            "address_2": "",
            "city": "Mansfield",
            "state_code": "MA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "02048"
          }
        }
      },
      "pma_number": "",
      "k_number": "DEN180055",
      "products": [
        {
          "product_code": "QIR",
          "created_date": "2024-12-11",
          "owner_operator_number": "10090982",
          "exempt": "",
          "openfda": {
            "k_number": [
              "DEN180055"
            ],
            "device_name": "Pediatric Hemodialysis System",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5861",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}