FDA Device Establishments · JSON-LD · Markdown
FEI 3038138522 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3038138522 |
|---|---|
| Owner / Operator | Outset Medical, Inc. (#10047467) |
| Address | Blv. Agua Caliente 8582-5, Zona Centro, Tijuana BC. Baja California, 22000, MX |
| Mandatory US Agent | Outset Medical Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | FIP, KDI |
| Regulation § (21 CFR) | 876.5665, 876.5860 |
| Proprietary names | Tablo Hemodialysis System |
Source: openFDA. Public-domain (CC0).