{
  "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": 13
    }
  },
  "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": "OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip",
      "public_device_record_key": "a0305ba8-1d3d-4d20-a3f3-bddb71e8097f",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Handling Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "90"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "10"
          }
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Do not refrigerate"
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "86"
          }
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Operating Altitude up to 10000 Feet"
        },
        {
          "type": "Handling Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "111"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "43"
          }
        }
      ],
      "public_version_date": "2025-12-05",
      "commercial_distribution_end_date": "2025-12-04",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "6",
      "labeler_duns_number": "480240820",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "20353885002671",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00353885002677",
          "quantity_per_package": "4",
          "package_discontinue_date": "2025-12-04",
          "package_status": "Not in Commercial Distribution",
          "package_type": "Shipper case"
        },
        {
          "id": "00353885002677",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "53885-911-01",
          "type": "Secondary",
          "issuing_agency": "NDC/NHRIC"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "021-911",
      "has_manufacturing_date": "true",
      "brand_name": "OneTouch Ultramini",
      "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",
      "customer_contacts": [
        {
          "phone": "+1(800)227-8862",
          "email": "XX@XX.XX"
        }
      ],
      "catalog_number": "021-911",
      "company_name": "LifeScan Europe GmbH",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62645",
          "name": "Glucose analyser IVD, home-use",
          "definition": "An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; 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. This analyser is typically included in a blood glucose monitoring system.",
          "implantable": "false",
          "code_status": "Active"
        },
        {
          "code": "45142",
          "name": "Blood lancing device tip",
          "definition": "A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        },
        {
          "code": "37243",
          "name": "Manual blood lancing device, reusable",
          "definition": "A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2017-09-13",
      "device_sizes": [
        {
          "type": "Needle Gauge",
          "value": "30",
          "unit": "Gauge"
        },
        {
          "type": "Device Size Text, specify",
          "text": "Hematocrit 30 - 55%"
        },
        {
          "type": "Device Size Text, specify",
          "text": "Blood Glucose measurement Level mg/dL"
        }
      ]
    }
  ]
}