FDA Device Establishments · JSON-LD · Markdown
FEI 3007495879 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3007495879 |
|---|---|
| Owner / Operator | STRYKER CORP. (#1811755) |
| Address | 31200 Solon Road, Unit 1, Solon, OH, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | LGZ, HIG, HRX |
| Regulation § (21 CFR) | 880.5725, 884.1700, 888.1100 |
| Proprietary names | LL0004 - Tubing Set Single Lumen Inflow with Dual Outflow; LL0002 Luer Lock Set Single Lumen; P2000 FluidSmart Fluid Management system (at the time of clearance, this was called Thermedx Fluid Management System |
Source: openFDA. Public-domain (CC0).