{
  "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": "OFG, CONNECTED 4G BLOOD PRESSURE MONITOR, BG95-M2 HT945",
      "public_device_record_key": "929f2302-efdc-4ca2-82d7-11a33fe8a5b0",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "140"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "-4"
          }
        },
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "93"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "0"
          }
        },
        {
          "type": "Handling Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "104"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "41"
          }
        },
        {
          "type": "Handling Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "90"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "15"
          }
        },
        {
          "type": "Handling Environment Atmospheric Pressure",
          "high": {
            "unit": "KiloPascal",
            "value": "106"
          },
          "low": {
            "unit": "KiloPascal",
            "value": "70"
          }
        }
      ],
      "public_version_date": "2025-10-20",
      "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": "00810079250004",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "HT945 - BG95-M2",
      "has_manufacturing_date": "true",
      "brand_name": "Teladoc Health, Inc.",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "DXN",
          "name": "System, Measurement, Blood-Pressure, Non-Invasive",
          "openfda": {
            "device_name": "System, Measurement, Blood-Pressure, Non-Invasive",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1130",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "1-800-945-4355",
          "email": "rc_team@teladochealth.com"
        }
      ],
      "catalog_number": "OFG000014",
      "company_name": "Teladoc Health, Inc.",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "16173",
          "name": "Automatic-inflation electronic sphygmomanometer, non-portable",
          "definition": "An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2025-10-10"
    }
  ]
}