{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SAF",
      "openfda": {
        "k_number": [
          "K233655",
          "K250106",
          "K234070"
        ],
        "registration_number": [
          "3009901017",
          "3009888344",
          "3013435121",
          "3027503105",
          "3010220595",
          "2029015",
          "3004753838",
          "3019807891",
          "3038285067",
          "2954323",
          "9710492",
          "3041000794",
          "3011536730",
          "3006371704",
          "3037326582"
        ],
        "fei_number": [
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          "3009901017",
          "3009888344",
          "3013435121",
          "3002803444",
          "3027503105",
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      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.",
      "regulation_number": "862.1355",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}