Janus Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Janus Biomedical, Inc. makes
Janus Biomedical, Inc. manufactures perfusion systems, including the JOSTRA HL-20 Integrated Perfusion System, designed for organ preservation and transport. The company also produces cryopreservation storage bags, such as the CRYOBAG, for storing biological tissues at low temperatures.
The company’s devices are regulated under FDA Class II and Class U classifications, with relevant products listed via the 510(k) pathway. These products are based in the United States.
Catalogue
Jostra Hl-20 Integrated Perfusion System Ref K943803
Regimes: 510(k) Registry: 510(k)Cryobag Ref K915471
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Janus Biomedical, Inc. have in the registry?
The registry currently lists 2 devices for Janus Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Janus Biomedical, Inc.'s devices?
Among its 2 most recently registered devices, Janus Biomedical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Janus Biomedical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Janus Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Janus Biomedical, Inc. in the registry?
The most recently registered devices listed for Janus Biomedical, Inc. include JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM and CRYOBAG.