{
  "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": 148
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Portex Reinforced Endotracheal Tube"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9617604",
        "fei_number": "3002558692",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ICU Medical Healthcare Manufacturing S.A. de C.V.",
        "address_line_1": "AVENIDA CALIDAD No 14409",
        "address_line_2": "Parque Industrial Internacional Tijuana",
        "city": "Tijuana, B.C. C.P. Baja California",
        "state_code": "",
        "iso_country_code": "MX",
        "zip_code": "",
        "postal_code": "22424",
        "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": "K830352",
      "products": [
        {
          "product_code": "BTR",
          "created_date": "2007-12-04",
          "owner_operator_number": "8020727",
          "exempt": "",
          "openfda": {
            "device_name": "Tube, Tracheal (W/Wo Connector)",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5730",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}