{
  "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": {
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    {
      "proprietary_name": [
        "TOMY HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)",
        "American Red Cross"
      ],
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        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
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        "fei_number": "3008687634",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2027",
        "name": "TOMY (Hong Kong) Limited",
        "address_line_1": "3101-2 & 12B, 31/F, Exchange Tower",
        "address_line_2": "33 Wang Chiu Road, Kowloon Bay",
        "city": "Kowloon, Hong Kong",
        "state_code": "",
        "iso_country_code": "HK",
        "zip_code": "",
        "postal_code": "999077",
        "us_agent": {
          "name": "Kenneth LI",
          "business_name": "Director of Product Integrity",
          "bus_phone_area_code": "630",
          "bus_phone_num": "5737350",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "kkli@tomy.com",
          "address_line_1": "2021 9th St. SE",
          "address_line_2": "",
          "city": "Dyersville",
          "state_code": "IA",
          "iso_country_code": "US",
          "zip_code": "52040",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "TOMY International Inc.",
          "owner_operator_number": "10033889",
          "official_correspondent": {
            "first_name": "Kenneth",
            "middle_initial": "",
            "last_name": "Li",
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            "phone_number": "852-630-5737350-x"
          },
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            "address_1": "Room 901-6, Tower 1, Enterprise Square",
            "address_2": "9 Sheung Yuet Road,",
            "city": "Kowloon Bay",
            "state_code": "HK-NOTA",
            "state_province": "",
            "iso_country_code": "HK",
            "postal_code": "0"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "KFZ",
          "created_date": "2010-10-14",
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          "exempt": "",
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            "device_name": "Humidifier, Non-Direct Patient Interface (Home-Use)",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5460",
            "device_class": "1"
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}