# Eli 380 ELI380-AAS11

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

- Canonical page: <https://devicerts.com/devices/eli-380-eli380-aas11>
- Manufacturer: [Mortara Instrument, Inc.](https://devicerts.com/manufacturers/mortara-instrument-inc) (United States, FDA 510(k) applicant)
- Name in the registry: ELI 380 ELI380-AAS11
- Device class: Class II (US FDA)
- FDA product code: DPS
- GMDN: Electrocardiograph, professional, multichannel (16231)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00812345026429 · listed 2016-09-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K142105 · decision 2014-09-05 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1013-2023 · Class II · terminated · initiated 2022-10-31: One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- Z-1483-2021 · Class II · terminated · initiated 2021-03-31: Devices do not meet IEC 60601-2-27 requirements as labeled.
- Z-1796-2015 · Class II · terminated · initiated 2015-05-29: Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.

## Identity

- Trade name: ELI 380 [FDA GUDID (AccessGUDID)]
- Generic name: Electrocardiograph, professional, multichannel [FDA GUDID (AccessGUDID)]
- Model / reference: ELI380-AAS11 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00812345026429 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K142105 [FDA GUDID (AccessGUDID)]
- FDA product code: DPS [FDA GUDID (AccessGUDID)]
- GMDN term: Electrocardiograph, professional, multichannel (16231) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.2340 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: 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)]
- 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)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Eli 380 ELI380-AAS11, Mortara Instrument, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/eli-380-eli380-aas11 (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: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/eli-380-eli380-aas11.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/eli-380-eli380-aas11
- 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.