{
  "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,
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  },
  "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": "OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters",
      "public_device_record_key": "e18ead12-4fe9-4ac4-9de6-a1db8fefa329",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Do Not Refrigerate"
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Store your test strips in their original vial only."
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Use within 6 months of opening test strip vial."
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "86"
          }
        }
      ],
      "public_version_date": "2026-04-13",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "144895694",
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      "identifiers": [
        {
          "id": "20353885009717",
          "type": "Package",
          "issuing_agency": "GS1",
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        },
        {
          "id": "53885-245-10",
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          "issuing_agency": "NDC/NHRIC"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "022-895",
      "has_manufacturing_date": "false",
      "brand_name": "OneTouch Ultra Blue",
      "is_combination_product": "false",
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        {
          "code": "CGA",
          "name": "GLUCOSE OXIDASE, GLUCOSE",
          "openfda": {
            "device_name": "Glucose Oxidase, Glucose",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1345",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "100",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)227-8862",
          "email": "XX@XX.XX"
        }
      ],
      "catalog_number": "022-895",
      "company_name": "LifeScan U.S. LLC",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "53303",
          "name": "Glucose IVD, kit, electrometry",
          "definition": "A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2017-09-13"
    }
  ]
}