{
  "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": "2026-07-20",
    "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": "NHV",
      "openfda": {
        "k_number": [
          "K173164",
          "K163609",
          "K153434",
          "K141731",
          "K182164",
          "K191563",
          "K153784",
          "K012716",
          "K222727",
          "K153084",
          "K161467"
        ],
        "registration_number": [
          "3012821221",
          "3014640782",
          "9680602",
          "3022699154",
          "3030626361",
          "3008412416",
          "3019907057",
          "3003337893",
          "3008102042",
          "3015136750",
          "3002807315",
          "3005695808",
          "3010132111",
          "3005698329",
          "9615942",
          "3005562917"
        ],
        "fei_number": [
          "3002924544",
          "3012821221",
          "3014640782",
          "1000191953",
          "1000268645",
          "3022699154",
          "3030626361",
          "3008412416",
          "3019907057",
          "3003337893",
          "3015136750",
          "3002807315",
          "3005695808",
          "3010132111",
          "3005698329",
          "3005562917"
        ]
      },
      "review_panel": "GU",
      "medical_specialty": "GU",
      "device_name": "System, Water Purification, General Medical Use",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Gastroenterology, Urology",
      "device_class": "2",
      "definition": "The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis.  The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists.  Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.",
      "regulation_number": "876.5665",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}