# Medivators Hookup

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/medivators-hookup-28112>
- Manufacturer: [Medivators Inc.](https://devicerts.com/manufacturers/medivators-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: FEB
- GMDN: Luminal device flushing tubing set, reusable (61723)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00677964071300 · listed 2023-04-10 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K172677 · decision 2017-12-19 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K102996 · decision 2011-01-13 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2538-2024 · Class II · ongoing · initiated 2024-06-13: 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
- Z-2536-2024 · Class II · ongoing · initiated 2024-06-13: 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
- Z-2537-2024 · Class II · ongoing · initiated 2024-06-13: 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
- Z-0617-2024 · Class II · ongoing · initiated 2023-11-13: 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.

## Identity

- Generic name: Luminal device flushing tubing set, reusable [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: Hookup [FDA GUDID (AccessGUDID)]; 28112 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00677964071300 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K102996 [FDA GUDID (AccessGUDID)]; K172677 [FDA GUDID (AccessGUDID)]
- FDA product code: FEB [FDA GUDID (AccessGUDID)]
- GMDN term: Luminal device flushing tubing set, reusable (61723) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 876.1500 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Medivators Hookup, Medivators Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/medivators-hookup-28112 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-21
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/medivators-hookup-28112.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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
- 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.