{
  "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": "2026-08-03",
    "results": {
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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": "System Kit, Blood Glucose Meter, AgaMatrix, Presto, mg/dL",
      "public_device_record_key": "cd2dd677-7d72-47be-aa04-8bd650d4e64f",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "86"
          },
          "low": {
            "unit": "Degrees Fahrenheit",
            "value": "46"
          }
        }
      ],
      "public_version_date": "2025-09-23",
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      "public_version_number": "5",
      "labeler_duns_number": "156756129",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
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          "type": "Package",
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          "unit_of_use_id": "00385542649017",
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          "package_status": "In Commercial Distribution",
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      "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"
          }
        }
      ],
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      "customer_contacts": [
        {
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          "email": "customerservice@agamatrix.com"
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      "company_name": "AgaMatrix, Inc.",
      "public_version_status": "Update",
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      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62537",
          "name": "Glucose monitoring system IVD, home-use",
          "definition": "A collection of devices including a portable, battery-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 for the quantitative measurement of glucose in a whole blood clinical specimen; 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.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-11-04"
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}