{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
    }
  },
  "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": "true",
      "commercial_distribution_status": "Not in Commercial Distribution",
      "device_description": "Wireless Blood Glucose Monitoring System. 1 Kit.\nFor Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.",
      "public_device_record_key": "c3a40fde-1fa5-4b4e-a9c0-908ced8e77d1",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "86"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "48"
          }
        },
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "80"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "10"
          }
        }
      ],
      "public_version_date": "2026-05-05",
      "commercial_distribution_end_date": "2026-05-01",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "080028910",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00301936260019",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "6260",
      "has_manufacturing_date": "false",
      "brand_name": "CONTOUR® NEXT LINK 2.4",
      "is_combination_product": "false",
      "is_kit": "true",
      "product_codes": [
        {
          "code": "OZO",
          "name": "Artificial Pancreas Device System, Threshold Suspend",
          "openfda": {
            "device_name": "Automated Insulin Dosing , Threshold Suspend",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "code": "OZP",
          "name": "Artificial Pancreas Device System, Single Hormonal Control",
          "openfda": {
            "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "P150001",
          "supplement_number": "000"
        },
        {
          "submission_number": "P160017",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "18003488100",
          "email": "support@contournext.com"
        }
      ],
      "catalog_number": "81914672",
      "company_name": "ASCENSIA DIABETES CARE US INC.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62537",
          "name": "Glucose monitoring system IVD, home-use",
          "definition": "A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-08-25"
    }
  ]
}