FDA Device Establishments · JSON-LD · Markdown
FEI 3011895992 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3011895992 |
|---|---|
| Owner / Operator | Gas Control Equipment LTD (#10056354) |
| Address | 100 Empress Park, Penny Lane, Haydock St. Helens, WA119DB, GB |
| Mandatory US Agent | Ohio Medical LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | CAW |
| Regulation § (21 CFR) | 868.5440 |
| Proprietary names | GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C; GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600; GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C; GCE Zen-O Portable Oxygen Concentrator Model RS-00500; ARYA Zen-O Lite Portable Oxygen Concentrator Model RS-00600 |
Source: openFDA. Public-domain (CC0).