# ROTEM® delta System (US/CA)

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

- Canonical page: <https://devicerts.com/devices/rotem-r-201001>
- Manufacturer: [Tem Innovations GmbH](https://devicerts.com/manufacturers/tem-innovations-gmbh) (FDA registration: Germany)
- Device class: Class II (US FDA)
- FDA product code: GGN, JPA
- GMDN: Coagulation analyser IVD, laboratory, semi-automated (56690)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 04260160470587 · listed 2018-03-15 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K083842 · decision 2010-03-23 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1090-2016 · Class II · terminated · initiated 2016-02-18: Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.
- Z-1379-2015 · Class II · terminated · initiated 2014-10-23: Some of vials were found to be partially filled.

## Identity

- Trade name: ROTEM® [FDA GUDID (AccessGUDID)]
- Generic name: Coagulation analyser IVD, laboratory, semi-automated [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: delta System (US/CA) [FDA GUDID (AccessGUDID)]; 201001 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04260160470587 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K083842 [FDA GUDID (AccessGUDID)]
- FDA product code: GGN [FDA GUDID (AccessGUDID)]; JPA [FDA GUDID (AccessGUDID)]
- GMDN term: Coagulation analyser IVD, laboratory, semi-automated (56690) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 864.5425 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

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

## Source and citation

- Cite as: ROTEM® delta System (US/CA), Tem Innovations GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/rotem-r-201001 (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: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/rotem-r-201001.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/rotem-r-201001
- 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.