{
  "format": "devicerts.device.v1",
  "cite_as": "Neozoline Ventilation Tubes, Adept Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/neozoline-ventilation-tubes-etd (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/neozoline-ventilation-tubes-etd",
    "json_url": "https://devicerts.com/devices/neozoline-ventilation-tubes-etd.json",
    "markdown_url": "https://devicerts.com/devices/neozoline-ventilation-tubes-etd.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-20",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/neozoline-ventilation-tubes-etd",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Neozoline Ventilation Tubes",
    "registry_name": "NEOZOLINE VENTILATION TUBES",
    "url": "https://devicerts.com/devices/neozoline-ventilation-tubes-etd",
    "manufacturer": {
      "name": "Adept Medical Ltd",
      "url": "https://devicerts.com/manufacturers/adept-medical-ltd",
      "country": "New Zealand",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class I",
        "system": "EU MDR / US FDA"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "09421901970895",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "942190197NZ3461-10079",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K061058",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "ETD",
      "JYH"
    ],
    "emdn": [
      {
        "code": "Q030306",
        "term": "ENT SURGERY CURETTES, SINGLE-USE"
      }
    ],
    "gmdn": [
      {
        "code": "65240",
        "term": "Tympanostomy tube inserter, single-use"
      }
    ],
    "description": {
      "text": "The Neozoline Ventilation Tubes are classified as tympanostomy tubes, designed for the surgical placement in the tympanic membrane to maintain middle ear aeration and drainage of fluid in conditions such as chronic otitis media with effusion. These tubes facilitate ventilation of the middle ear, reducing pressure and preventing recurrent infections by allowing fluid to escape while permitting airflow.\n\nThese tubes are supplied sterile and intended for single-use. They are classified under FDA device class II and comply with the MDR (Medical Device Regulation). Available in multiple sizes and reference codes (e.g., 3013557562, 1045254), they are regulated under the product code ETD and are intended for use in otolaryngological procedures. Storage and handling must adhere to sterile medical device protocols to ensure safety and efficacy.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "942190197NZ3461-10079",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "09421901970895",
      "date": "2024-11-18",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "09421901970895",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2024-04-23",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K061058",
      "number_label": null,
      "device_udi_di": null,
      "date": "2006-07-12",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0966-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    },
    {
      "number": "Z-0969-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    },
    {
      "number": "Z-0965-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    },
    {
      "number": "Z-0970-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    },
    {
      "number": "Z-0967-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    },
    {
      "number": "Z-0963-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    },
    {
      "number": "Z-0968-2025",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-11-24",
      "reason": "Lack of 510(k) clearance.",
      "applies": "this device",
      "via": "K061058"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "NeoZoline",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Rosen Inserter",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Tympanostomy tube inserter, single-use",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "NZ3461-100",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "09421901970895",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
          "values": [
            {
              "value": "942190197NZ3461-10079",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Direct marketing DI",
          "values": [
            {
              "value": "09421901970895",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K061058",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "ETD",
              "registries": [
                "FDA 510(k)"
              ]
            },
            {
              "value": "JYH",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "Q030306",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Tympanostomy tube inserter, single-use",
              "code": "65240",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class I",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 874.3880",
              "registries": [
                "FDA 510(k)"
              ]
            },
            {
              "value": "874.4420",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "France",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ear, Nose, Throat",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Single use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Premarket exempt",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Lot / batch number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Reusable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains endocrine-disrupting substances",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Administering medicine",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Prescription use",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Over-the-counter",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Convenience kit",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Combination product",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "HCT/P",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Expiration date",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    }
  ]
}