{
  "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": "2026-07-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "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": "Accu-Chek Fastclix MO/RP/AST Kit USA",
      "public_device_record_key": "b142c5ef-7ec9-40f2-93be-5e66dda0739f",
      "has_serial_number": "false",
      "public_version_date": "2022-12-09",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "313212471",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00365702481107",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "10365702481104",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00365702481107",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "05864666160",
      "has_manufacturing_date": "false",
      "brand_name": "Accu-Chek Fastclix",
      "is_combination_product": "false",
      "is_kit": "true",
      "product_codes": [
        {
          "code": "QRL",
          "name": "Multiple Use Blood Lancet For Single Patient Use Only",
          "openfda": {
            "device_name": "Multiple Use Blood Lancet For Single Patient Use Only",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4850",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "05864666160",
      "company_name": "Roche Diabetes Care GmbH",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "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"
        },
        {
          "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"
        }
      ],
      "publish_date": "2022-09-27"
    }
  ]
}