{
  "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": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Accuflex® single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer is easy to use and provides fast readings. Most importantly, Accuflex is reliable and accurate for patients of all ages.\nAccurate within ± 0.1°C in the 35°C to 42°C range\nFast response time: 10 seconds\nWashable for easy cleaning\nGentle-flex tip for patient comfort\nAuto shut-off feature\nMemory recall / display of last 30 readings\nIndividually packaged, includes storage case\nAnti-Bacterial additive\nConvenient colour codes – blue for oral and red for rectal",
      "public_device_record_key": "daeeb53a-9ac9-48e4-8dad-afb19f8cde46",
      "has_serial_number": "false",
      "public_version_date": "2025-12-15",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "207372814",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00057565972846",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00057565166283",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution"
        },
        {
          "id": "00057565166283",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "00057565972754",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00057565972846",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution",
          "package_type": "Master Case"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "016-628",
      "has_manufacturing_date": "false",
      "brand_name": "Physio Logic Accuflex Digital Thermometer",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FLL",
          "name": "Thermometer, Electronic, Clinical",
          "openfda": {
            "device_name": "Continuous Measurement Thermometer",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.2910",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "016-628",
      "company_name": "A.M.G. Médicale Inc",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "14035",
          "name": "Intermittent electronic patient thermometer",
          "definition": "A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2023-06-09"
    }
  ]
}