The Henry G. Dietz Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What The Henry G. Dietz Co., Inc. makes
The Henry G. Dietz Co., Inc. manufactures the HALA’TUS 1 OXYGENATOR, a medical device used in cardiopulmonary bypass procedures to oxygenate and deoxygenate blood, and the BREATH EXPOSURE SYNCHRONIZER (BES), which coordinates ventilatory support with other respiratory interventions during surgery or critical care.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Hala'tus 1 Oxygenator Ref K903504
Regimes: 510(k) Registry: 510(k)Bes - Breath Exposure Synchronizer Ref K942581
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Henry G. Dietz Co., Inc. have in the registry?
The registry currently lists 2 devices for The Henry G. Dietz Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Henry G. Dietz Co., Inc.'s devices?
Among its 2 most recently registered devices, The Henry G. Dietz Co., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do The Henry G. Dietz Co., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for The Henry G. Dietz Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Henry G. Dietz Co., Inc. in the registry?
The most recently registered devices listed for The Henry G. Dietz Co., Inc. include HALA'TUS 1 OXYGENATOR and BES - BREATH EXPOSURE SYNCHRONIZER.