{
  "format": "devicerts.device.v1",
  "cite_as": "Medivators Hookup, Medivators Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/medivators-hookup-28112 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/medivators-hookup-28112",
    "json_url": "https://devicerts.com/devices/medivators-hookup-28112.json",
    "markdown_url": "https://devicerts.com/devices/medivators-hookup-28112.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-21",
    "status_as_of": "2026-11-14",
    "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/medivators-hookup-28112",
    "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": "Medivators Hookup",
    "registry_name": "Medivators Hookup",
    "url": "https://devicerts.com/devices/medivators-hookup-28112",
    "manufacturer": {
      "name": "Medivators Inc.",
      "url": "https://devicerts.com/manufacturers/medivators-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "28112",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00677964071300",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K102996",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          },
          {
            "value": "K172677",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "FEB"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "61723",
        "term": "Luminal device flushing tubing set, reusable"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00677964071300",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2023-04-10",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K172677",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-12-19",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K102996",
      "number_label": null,
      "device_udi_di": null,
      "date": "2011-01-13",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-2538-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-06-13",
      "reason": "IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection",
      "applies": "this device",
      "via": "K102996"
    },
    {
      "number": "Z-2536-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-06-13",
      "reason": "IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection",
      "applies": "this device",
      "via": "K102996"
    },
    {
      "number": "Z-2537-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-06-13",
      "reason": "IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection",
      "applies": "this device",
      "via": "K102996"
    },
    {
      "number": "Z-0617-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-11-13",
      "reason": "Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.",
      "applies": "this device",
      "via": "K102996"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Luminal device flushing tubing set, reusable",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
          "values": [
            {
              "value": "Hookup",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "28112",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
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            {
              "value": "00677964071300",
              "registries": [
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          "label": "510(k) Number",
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          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "FEB",
              "registries": [
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            }
          ]
        },
        {
          "label": "GMDN term",
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            {
              "value": "Luminal device flushing tubing set, reusable",
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation number",
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            {
              "value": "876.1500",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
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        {
          "label": "Lot / batch number",
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            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Supplied sterile",
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            {
              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Single use",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Implantable",
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            {
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Contains latex",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
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        {
          "label": "Prescription use",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Over-the-counter",
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            {
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Convenience kit",
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              "registries": [
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            }
          ]
        },
        {
          "label": "Combination product",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "HCT/P",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Premarket exempt",
          "values": [
            {
              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Serial number",
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            {
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              "registries": [
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            }
          ]
        },
        {
          "label": "Expiration date",
          "values": [
            {
              "value": "No",
              "registries": [
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            }
          ]
        }
      ]
    }
  ]
}