{
  "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": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "PZE",
      "openfda": {
        "pma_number": [
          "P160030"
        ],
        "registration_number": [
          "9710492",
          "3008606429",
          "3010893867",
          "2954323",
          "3009171251",
          "3002807314",
          "3006371704",
          "3003600763",
          "3007421145",
          "3004139819",
          "3011536730"
        ],
        "fei_number": [
          "3008606429",
          "3010893867",
          "3002807314",
          "3003500908",
          "3004173703",
          "3006371704",
          "3003600763",
          "3002803444",
          "3006759904",
          "3004139819",
          "3011536730"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "",
      "device_name": "Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and  does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}