{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "proprietary_name": [
        "BD Stretch Tourniquet Strap",
        "Hygenic Hysynal Tourniquet Strap"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9681338",
        "fei_number": "3003123739",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "The Hygenic Corporation",
        "address_line_1": "Plot 6 Bemban Industrial Park",
        "address_line_2": "",
        "city": "Batu Gajah Perak",
        "state_code": "",
        "iso_country_code": "MY",
        "zip_code": "",
        "postal_code": "31000",
        "us_agent": {
          "name": "Melanie Leibowitz",
          "business_name": "",
          "bus_phone_area_code": "331",
          "bus_phone_num": "6889688",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "melanie.leibowitz@performancehealth.com",
          "address_line_1": "3333 Finley Rd Ste 575",
          "address_line_2": "",
          "city": "Downers Grove",
          "state_code": "IL",
          "iso_country_code": "US",
          "zip_code": "60515",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "The Hygenic Company, LLC",
          "owner_operator_number": "1519375",
          "official_correspondent": {
            "first_name": "Melanie",
            "middle_initial": "-",
            "last_name": "Leibowitz",
            "subaccount_company_name": "",
            "phone_number": "x-331-6889688-x"
          },
          "contact_address": {
            "address_1": "1245 Home Ave",
            "address_2": "",
            "city": "Akron",
            "state_code": "OH",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "44310"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "GAX",
          "created_date": "1995-09-05",
          "owner_operator_number": "1519375",
          "exempt": "",
          "openfda": {
            "device_name": "Tourniquet, Nonpneumatic",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.5900",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}