{
  "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": 57
    }
  },
  "results": [
    {
      "proprietary_name": [
        "AMICUS Apheresis Kit - Single Needle with Platelet Additive Solution Connector",
        "AMICUS Apheresis Kit - Double Needle with Inlet Line Sampling",
        "Amicus Apheresis Kit - Single Needle",
        "AMICUS Apheresis Kit - Double Needle with Platelet Additive Solution Connector"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9612051",
        "fei_number": "3002806457",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "FENWAL INTERNATIONAL, INC.",
        "address_line_1": "CARRETERA SANCHEZ KM 18.5",
        "address_line_2": "PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C.",
        "city": "HAINA San Cristobal",
        "state_code": "",
        "iso_country_code": "DO",
        "zip_code": "",
        "postal_code": "--",
        "us_agent": {
          "name": "Rhoda Lynn Valera",
          "business_name": "",
          "bus_phone_area_code": "847",
          "bus_phone_num": "5502929",
          "bus_phone_extn": "",
          "fax_area_code": "847",
          "fax_num": "5502960",
          "email_address": "rhoda.valera@fresenius-kabi.com",
          "address_line_1": "3 Corporate Dr",
          "address_line_2": "",
          "city": "Lake Zurich",
          "state_code": "IL",
          "iso_country_code": "US",
          "zip_code": "60047",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Fresenius Kabi AG",
          "owner_operator_number": "9027285",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Else-Kroner-Str. 1",
            "address_2": "",
            "city": "61352 Bad Homburg",
            "state_code": "DE-NOTA",
            "state_province": "",
            "iso_country_code": "DE",
            "postal_code": "NONE"
          }
        }
      },
      "pma_number": "",
      "k_number": "BK150242",
      "products": [
        {
          "product_code": "GKT",
          "created_date": "2015-11-25",
          "owner_operator_number": "9027285",
          "exempt": "",
          "openfda": {
            "device_name": "Separator, Automated, Blood Cell, Diagnostic",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.9245",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}