{
  "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": "Thermometer, Braun Infrared ThermoScan Ear w/21 filters - for intermittent measurement of temperature for patients of all ages, this thermometer is used with lens filters.",
      "public_device_record_key": "f6177d9c-5736-4d7a-9cb9-a6913d19696a",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "95"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "15"
          }
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "131"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "-13"
          }
        }
      ],
      "public_version_date": "2026-02-16",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "5",
      "labeler_duns_number": "122612547",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10328785000099",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00328785000092",
          "quantity_per_package": "6",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        },
        {
          "id": "00328785000092",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "IRT6020US",
      "has_manufacturing_date": "false",
      "brand_name": "Braun",
      "is_combination_product": "false",
      "is_kit": "true",
      "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": "false",
      "customer_contacts": [
        {
          "phone": "1-800-327-7226",
          "email": "consumerrelations@kaz.com"
        }
      ],
      "catalog_number": "IRT6020US",
      "company_name": "KAZ USA, INC.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "17887",
          "name": "Infrared patient thermometer, ear",
          "definition": "A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-09-09"
    }
  ]
}