Alung Technologies, Inc.
Country not established
- Devices
- 10
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Alung Technologies, Inc. makes
Alung Technologies, Inc. manufactures the Hemolung Respiratory Assist System, a device designed to provide extracorporeal membrane oxygenation (ECMO) support for patients with severe respiratory failure.
The Hemolung Respiratory Assist System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) clearance pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Hemolung Respiratory Assist System Ref DEN210006
Regimes: De Novo Registry: De Novo
Company details
- DUNS number
- 129408592
- [email protected]
- Phone
- (412) 697-3370
FDA recalls
FDA recall records list 1 recall initiated by Alung Technologies, Inc., initiated on 2020-12-18. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 18 Dec 2020 Z-0938-2021 Class II Terminated CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy
Frequently asked questions
How many devices does Alung Technologies, Inc. have in the registry?
The registry currently lists 10 devices for Alung Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alung Technologies, Inc.'s devices?
Among its 10 most recently registered devices, Alung Technologies, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alung Technologies, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Alung Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alung Technologies, Inc.?
FDA recall records list 1 recall initiated by Alung Technologies, Inc., the most recent initiated on 18 Dec 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Alung Technologies, Inc. in the registry?
The most recently registered devices listed for Alung Technologies, Inc. include Hemolung® Accessories Kit 40200, Hemolung® 15.5 Fr Jugular Catheter Kit 40900, Hemolung® CR4 Controller 21000 and Hemolung® Cartridge Spare Parts Kit 41200.