{
  "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,
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    }
  },
  "results": [
    {
      "proprietary_name": [
        "Inflation Syringe for Rectal Balloon",
        "MASK INFLATION BULB",
        "BULB SYRINGES"
      ],
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        "Export Device to the United States But Perform No Other Operation on Device",
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
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        "fei_number": "3003413553",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.",
        "address_line_1": "100 Zhongde Road, Building No.6",
        "address_line_2": "Xiaokunshan Town",
        "city": "Songjiang Shanghai",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "201614",
        "us_agent": {
          "name": "Matt Dryden",
          "business_name": "Promedic, LLC",
          "bus_phone_area_code": "239",
          "bus_phone_num": "3076063",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "matt.dryden@promedic.cc",
          "address_line_1": "131 Bay Point Dr NE",
          "address_line_2": "",
          "city": "Saint Petersburg",
          "state_code": "FL",
          "iso_country_code": "US",
          "zip_code": "33704",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "KOO MFG, INC.",
          "owner_operator_number": "9012237",
          "official_correspondent": {
            "first_name": "CHRISTOPHER",
            "middle_initial": "-",
            "last_name": "KOO",
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            "phone_number": "86-21-5785841-x"
          },
          "contact_address": {
            "address_1": "100 Zhongde Road",
            "address_2": "Dakun Indurstrial Park",
            "city": "Songjiang",
            "state_code": "CN-SH",
            "state_province": "Shanghai",
            "iso_country_code": "CN",
            "postal_code": "201613"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "KYZ",
          "created_date": "2006-04-27",
          "owner_operator_number": "9012237",
          "exempt": "",
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            "device_name": "Syringe, Irrigating (Non Dental)",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.6960",
            "device_class": "1"
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}