FDA Device Establishments · JSON-LD · Markdown
FEI 3008454189 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3008454189 |
|---|---|
| Owner / Operator | Berlin Heart, Inc. (#10039498) |
| Address | 9391 Grogan's Mill Road, Suite A-6, The Woodlands, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | DSQ |
| Proprietary names | EXCOR® Pediatric Ventricular Assist Device |
Source: openFDA. Public-domain (CC0).