{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "ODX",
      "openfda": {
        "k_number": [
          "K103242",
          "K092955",
          "K130554",
          "K071013"
        ],
        "registration_number": [
          "1225714",
          "3015335038",
          "3013791928",
          "3004111573",
          "1650907",
          "3006948863",
          "8030665",
          "9680579"
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        "fei_number": [
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          "3002681132"
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      },
      "review_panel": "GU",
      "medical_specialty": "GU",
      "device_name": "Autonomous Extracorporeal Blood Leak Detector/Alarm",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Gastroenterology, Urology",
      "device_class": "2",
      "definition": "To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff.  The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.",
      "regulation_number": "876.5820",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}