FDA Device Establishments · JSON-LD · Markdown
FEI 3019004087 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3019004087 |
|---|---|
| Owner / Operator | Beta Bionics, Inc. (#10088071) |
| Address | 11 Hughes, Irvine, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QFG |
| Regulation § (21 CFR) | 880.5730 |
| Proprietary names | iLet Cartridge Kit; iLet Bionic Pancreas: iLet ACE Pump; iLet Charger; iLet Case, iLet Clip; iLet Connect Adapter |
Source: openFDA. Public-domain (CC0).