{
  "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": 4
    }
  },
  "results": [
    {
      "proprietary_name": [
        "P3T Abdomen",
        "MEDRAD® Stellant Imaging System Interface Module",
        "MEDRAD Stellant CT Injection System with Certegra Workstation",
        "MEDRAD Stellant FLEX Syringe Kits",
        "Connect.CT",
        "P3T Cardiac",
        "MEDRAD Stellant Syringe Kits",
        "MEDRAD Stellant Connector Tubing",
        "MEDRAD Stellant FLEX CT Injection System with Certegra Workstation",
        "P3T PA",
        "MEDRAD Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike (SDS-CTP-SCS)",
        "MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Spike (FLEXS-150-SPK)",
        "MEDRAD Stellant Single Syringe with QFT (SSS-QFT)",
        "Imaging System Interface - ISI2 Module",
        "MEDRAD Stellant Single Syringe Tri-Pak with Spike (SSS-CTP-SPK)",
        "MEDRAD Stellant Single Syringe Tri-Pak with QFT (SSS-CTP-QFT)"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3006791331",
        "fei_number": "3006791331",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Bayer Medical Care Inc.",
        "address_line_1": "150 Victory Road",
        "address_line_2": "",
        "city": "Saxonburg",
        "state_code": "PA",
        "iso_country_code": "US",
        "zip_code": "16056",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Bayer Medical Care Inc.",
          "owner_operator_number": "2520313",
          "official_correspondent": {
            "first_name": "Troy",
            "middle_initial": "A",
            "last_name": "Jack",
            "subaccount_company_name": "",
            "phone_number": "x-412-3528280-x"
          },
          "contact_address": {
            "address_1": "1 Bayer Drive",
            "address_2": "",
            "city": "Indianola",
            "state_code": "PA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "15051"
          }
        }
      },
      "pma_number": "",
      "k_number": "K182273",
      "products": [
        {
          "product_code": "DXT",
          "created_date": "2022-04-12",
          "owner_operator_number": "2520313",
          "exempt": "",
          "openfda": {
            "device_name": "Injector And Syringe, Angiographic",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1650",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}