{
  "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": 12
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Pencil Point Spinal Needle",
        "Single Shot Epidural tray/kit",
        "Continuous Epidural tray/kit",
        "Portex combined Spinal/Epidural Minipack",
        "Spinal tray/kit",
        "Portex Epidural Minipack System",
        "Portex Regional Anesthesia Catheter Connector"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3011237704",
        "fei_number": "3011237704",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ICU Medical Czech Republic a. s.",
        "address_line_1": "Olomoucka 306",
        "address_line_2": "",
        "city": "Hranice Olomoucky Kraj",
        "state_code": "",
        "iso_country_code": "CZ",
        "zip_code": "",
        "postal_code": "753 01",
        "us_agent": {
          "name": "Michelle Doherty",
          "business_name": "ICU Medical, Inc.",
          "bus_phone_area_code": "949",
          "bus_phone_num": "3706562",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "michelle.doherty@icumed.com",
          "address_line_1": "951 Calle Amanecer",
          "address_line_2": "",
          "city": "San Clemente",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "92673",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "ICU Medical, Inc.",
          "owner_operator_number": "8020727",
          "official_correspondent": {
            "first_name": "Michelle",
            "middle_initial": "",
            "last_name": "Doherty",
            "subaccount_company_name": "",
            "phone_number": "x-949-3706562-x"
          },
          "contact_address": {
            "address_1": "951 Calle Amanecer",
            "address_2": "",
            "city": "San Clemente",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "92673"
          }
        }
      },
      "pma_number": "",
      "k_number": "K965017",
      "products": [
        {
          "product_code": "CAZ",
          "created_date": "1993-01-13",
          "owner_operator_number": "8020727",
          "exempt": "",
          "openfda": {
            "device_name": "Anesthesia Conduction Kit",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5140",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}