{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QAX",
      "openfda": {
        "k_number": [
          "DEN190042"
        ],
        "registration_number": [
          "9611369",
          "3038195011"
        ],
        "fei_number": [
          "3002807035",
          "3038195011"
        ]
      },
      "review_panel": "GU",
      "medical_specialty": "GU",
      "device_name": "Hemodialyzer With Expanded Solute Removal Profile",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Gastroenterology, Urology",
      "device_class": "2",
      "definition": "A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa).",
      "regulation_number": "876.5862",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}