Data / Medical devices / Unit, Liquid-Oxygen, Portable
Unit, Liquid-Oxygen, Portable (BYJ): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Unit, Liquid-Oxygen, Portable (product code BYJ, Class 2, 21 CFR 868.5655). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 55 510(k) clearances under this code, the latest on July 19, 2013, and lists 3 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- BYJ
- Device class
- 2
- Regulation
- 868.5655
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 1 |
Makers of Unit, Liquid-Oxygen, Portable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Caire Inc. | Ball Ground, GA, United States | Manufacturer | 6 | June 16, 2008 | 0 | 0 | 0 | api.fda.gov |
| Caire Inc. | Ball Ground, GA, United States | Specification developer | 6 | June 16, 2008 | 0 | 2 | 1 | api.fda.gov |
| Essex Industries, Inc | Affton, MO, United States | Manufacturer, Remanufacturer | 3 | June 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| DEHAS Medical Systems GmbH | Luebeck Schleswig-Holstein, Germany | Manufacturer | 2 | April 21, 2011 | 0 | 0 | 0 | api.fda.gov |
Updated July 19, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.