{
  "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": 12
    }
  },
  "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": "Precision Xtra Blood Glucose Test Strips",
      "public_device_record_key": "e8d2a867-cd83-44c5-b1d9-c1bc82a3a869",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "86"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "39"
          }
        }
      ],
      "public_version_date": "2023-10-18",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "966390890",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "30093815996959",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00093815996958",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution",
          "package_type": "Case"
        },
        {
          "id": "00093815996958",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "57599-9695-4",
          "type": "Secondary",
          "issuing_agency": "NDC/NHRIC"
        },
        {
          "id": "10093815996955",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "99695",
      "has_manufacturing_date": "false",
      "brand_name": "Precision Xtra",
      "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"
          }
        },
        {
          "code": "LFR",
          "name": "Glucose dehydrogenase, glucose",
          "openfda": {
            "device_name": "Glucose Dehydrogenase, Glucose",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1345",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K051213",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "50",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)527-3339",
          "email": "xx@xx.xx"
        }
      ],
      "catalog_number": "99695",
      "company_name": "ABBOTT DIABETES CARE INC",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62644",
          "name": "Multiple clinical chemistry analyte monitoring system IVD, point-of-care",
          "definition": "A collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.",
          "implantable": "false",
          "code_status": "Active"
        },
        {
          "code": "62643",
          "name": "Multiple clinical chemistry analyte monitoring system IVD, home-use",
          "definition": "A collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-07-22"
    }
  ]
}