{
  "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": "BG500 Blood Glucose Meter",
      "public_device_record_key": "993ff87e-2057-4c5c-8c20-e806e032b7ec",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Handling Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "113"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "41"
          }
        },
        {
          "type": "Handling Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "90"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "10"
          }
        },
        {
          "type": "Handling Environment Atmospheric Pressure",
          "high": {
            "unit": "KiloPascal",
            "value": "101"
          },
          "low": {
            "unit": "KiloPascal",
            "value": "75"
          }
        },
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "90"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "10"
          }
        }
      ],
      "public_version_date": "2026-02-25",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "079408533",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00810079240531",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "BG500",
      "has_manufacturing_date": "false",
      "brand_name": "Teladoc Health, Inc.",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "NBW",
          "name": "System, Test, Blood Glucose, Over The Counter",
          "openfda": {
            "device_name": "System, Test, Blood Glucose, Over The Counter",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1345",
            "device_class": "2"
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        }
      ],
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      "is_pm_exempt": "false",
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      "customer_contacts": [
        {
          "phone": "1-800-945-4355",
          "email": "rc_team@teladochealth.com"
        }
      ],
      "catalog_number": "FG000005",
      "company_name": "Teladoc Health, Inc.",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62645",
          "name": "Glucose analyser IVD, home-use",
          "definition": "An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-02-17"
    }
  ]
}