{
  "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": "The AUVON DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The AUVON DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. \nThe AUVON DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AUVON DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). \nThe AUVON DS-W Draw-in Blood Glucose Test Strips are for use with the AUVON DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.",
      "public_device_record_key": "7b9c5756-5595-4b65-b2fe-0dd20c4480e4",
      "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": "1",
      "labeler_duns_number": "765349382",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00850080988077",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00850080988060",
          "quantity_per_package": "2",
          "package_status": "In Commercial Distribution"
        },
        {
          "id": "00850080988060",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "00850080988084",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00850080988060",
          "quantity_per_package": "4",
          "package_status": "In Commercial Distribution"
        },
        {
          "id": "10850080988067",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "DS-W",
      "has_manufacturing_date": "false",
      "brand_name": "AUVON",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "CGA",
          "name": "Glucose Oxidase, Glucose",
          "openfda": {
            "device_name": "Glucose Oxidase, Glucose",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1345",
            "device_class": "2"
          }
        },
        {
          "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"
          }
        }
      ],
      "device_count_in_base_package": "75",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(678)829-7256",
          "email": "support@iauvon.com"
        }
      ],
      "company_name": "UAN HEALTHCARE LIMITED",
      "public_version_status": "New",
      "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": "2026-02-06"
    }
  ]
}