{
  "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,
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  "results": [
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      "proprietary_name": [
        "CATHETER RETENTION BARIUM WITH BAG, RTB BULK PACK,1001-1 SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF, 1001-11",
        "CATHETER RETENTION BARIUM WITH BAG, Flexi-Tip, 1001-30, 1001-32, 1001-36",
        "CATHETER RETENTION BARIUM WITH BAG, NS TUBING CLAMP, EZEM-848",
        "Enema delivery system",
        "CATHETER, RETENTION, BARIUM ENEMA WITH BAG, 1001-21, Exacta-I screw cap",
        "Non Latex, air retention tip, 1001-025",
        "CATHETER RETENTION BARIUM WITH BAG,AIR BULB INSUFLATOR,1001-37,ONE SHOT CUFF INFLATOR 1001-38, XL MILLER AIRTIP,1001-84",
        "Rounded Flex-Tip, 1001-28",
        "Barium Enema Ring, 1001-20"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "3010291427",
        "fei_number": "3010291427",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "AvailMed S.A.De C.V.",
        "address_line_1": "C.Industrial Lt.001 Mz.105",
        "address_line_2": "No. 20905 Int.A. Col. Cd. Industrial",
        "city": "Tijuana Baja California",
        "state_code": "",
        "iso_country_code": "MX",
        "zip_code": "",
        "postal_code": "C.P. 22444",
        "us_agent": {
          "name": "Nicholas Mandala",
          "business_name": "FLEXTRONICS INTERNATIONAL USA, INC.",
          "bus_phone_area_code": "201",
          "bus_phone_num": "5227811",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "nicholas.mandala@flex.com",
          "address_line_1": "12455 Research Blvd",
          "address_line_2": "",
          "city": "Austin",
          "state_code": "TX",
          "iso_country_code": "US",
          "zip_code": "78759",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Flextronics International USA, Inc.",
          "owner_operator_number": "9006592",
          "official_correspondent": {
            "first_name": "Nicholas",
            "middle_initial": "",
            "last_name": "Mandala",
            "subaccount_company_name": "",
            "phone_number": "1-201-5227811-x"
          },
          "contact_address": {
            "address_1": "12455 Research Blvd",
            "address_2": "",
            "city": "Austin",
            "state_code": "TX",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "78759"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "FGD",
          "created_date": "2015-01-08",
          "owner_operator_number": "9006592",
          "exempt": "",
          "openfda": {
            "device_name": "Catheter, Retention, Barium Enema With Bag",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5980",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}