{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 15
    }
  },
  "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",
      "public_device_record_key": "b4847076-3c14-4b36-8ff5-8b0bf26731dd",
      "has_serial_number": "true",
      "public_version_date": "2018-03-29",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "203383526",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00627825003742",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "AQS3002",
      "has_manufacturing_date": "true",
      "brand_name": "Aquarius XT",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FEN",
          "name": "DEVICE, CYSTOMETRIC, HYDRAULIC",
          "openfda": {
            "device_name": "Device, Cystometric, Hydraulic",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1620",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "false",
      "company_name": "Laborie Medical Technologies Canada ULC",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "14307",
          "name": "Urodynamic measurement system",
          "definition": "An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-09-21"
    }
  ]
}