# Gyrus ACMI 240046

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

- Canonical page: <https://devicerts.com/devices/gyrus-acmi-240046>
- Manufacturer: [Gyrus Acmi, Inc.](https://devicerts.com/manufacturers/gyrus-acmi-inc) (United States)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: ETD
- EMDN: Q03040199 EAR DRAINAGE AND VENTILATION DEVICES - OTHER
- GMDN: Tympanostomy tube (33794)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00821925020009 · UDI-DI 00821925020009 · registered 2026-09-09 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00821925020009 · listed 2016-10-11 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K932166 · decision 1993-07-26 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0707-2025 · Class II · ongoing · initiated 2024-11-19: Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
- Z-1004-2024 · Class II · ongoing · initiated 2023-12-11: The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

## Identity

- Trade name: Gyrus ACMI [FDA GUDID (AccessGUDID)]
- Generic name: Tympanostomy tube [FDA GUDID (AccessGUDID)]
- Device name: 240046 [EUDAMED]
- Model / reference: 240046 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00821925020009 [EUDAMED]; 00821925032200 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00821925020009 [EUDAMED]
- 510(k) Number: K932166 [FDA GUDID (AccessGUDID)]
- FDA product code: ETD [FDA GUDID (AccessGUDID)]
- EMDN code: Q03040199 [EUDAMED]
- GMDN term: Tympanostomy tube (33794) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 874.3880 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED]; Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Gyrus ACMI 240046, Gyrus Acmi, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/gyrus-acmi-240046 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/gyrus-acmi-240046.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/gyrus-acmi-240046
- 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.