FDA Device Establishments · JSON-LD · Markdown
FEI 3015882716 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3015882716 |
|---|---|
| Owner / Operator | GastroKlenz Inc. dba CloudCath (#10085457) |
| Address | 665 3rd Street, Suite 250, San Francisco, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FKX |
| Regulation § (21 CFR) | 876.5630 |
| Proprietary names | CloudCath; CloudCath Drain Set - Baxter Configuration; CloudCath Drain Set - Fresenius Configuration; CloudCath Sensor (Sensing Hardware); CloudCath Connect - Patient Monitoring Software |
Source: openFDA. Public-domain (CC0).