{
  "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": 4
    }
  },
  "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": "Not in Commercial Distribution",
      "device_description": "ACCU-CHEK AVIVA CONNECT RETAIL  KIT 8/CASE",
      "public_device_record_key": "8183912f-32f7-41b7-9a80-dacdc1aa6069",
      "has_serial_number": "true",
      "public_version_date": "2023-07-06",
      "commercial_distribution_end_date": "2018-07-03",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "4",
      "labeler_duns_number": "141608724",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10365702577104",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00365702577107",
          "quantity_per_package": "8",
          "package_discontinue_date": "2018-07-03",
          "package_status": "Not in Commercial Distribution"
        },
        {
          "id": "00365702577107",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "07049706001",
      "has_manufacturing_date": "false",
      "brand_name": "ACCU-CHEK AVIVA CONNECT",
      "is_combination_product": "false",
      "is_kit": "true",
      "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"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "07049706001",
      "company_name": "Roche Diagnostics Operations, Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "53301",
          "name": "Glucose IVD, kit, spectrophotometry",
          "definition": "A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-08-26"
    }
  ]
}