{
  "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,
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    }
  },
  "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": "Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package contains 20 probe covers. Not for individual sale.\nThe probe cover is intended for use as a sanitary barrier between the thermometer and ear canal.",
      "public_device_record_key": "96627d72-b910-4bdb-9afe-8c266b7de182",
      "has_serial_number": "false",
      "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": "00328785000535",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "10328785000365",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "PC20KB",
      "has_manufacturing_date": "false",
      "brand_name": "Braun",
      "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": "20",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "1-800-535-6663",
          "email": "customerservice@welchallyn.com"
        }
      ],
      "company_name": "KAZ USA, INC.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "13116",
          "name": "Electronic thermometer probe cover",
          "definition": "A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-08-29"
    }
  ]
}