FDA Device Establishments · JSON-LD · Markdown
FEI 3012172416 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3012172416 |
|---|---|
| Owner / Operator | Xenios AG (#10045964) |
| Address | Im Zukunftspark 1, Heilbronn Baden-Wurttemberg, 74076, DE |
| Mandatory US Agent | Fresenius Medical Care North America |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QJZ |
| Regulation § (21 CFR) | 870.4100 |
| Proprietary names | Novalung battery pack; Novalung System; Novalung sensor box; Novalung power supply; XLung kit; IPS Pressure Sensor connecting cable; Compact holder; Novalung console; Flow Sensor 3/8x3/32; Trolley N |
Source: openFDA. Public-domain (CC0).