FDA Device Establishments · JSON-LD · Markdown
FEI 3002806988 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3002806988 |
|---|---|
| Owner / Operator | FISHER & PAYKEL HEALTHCARE NZ LTD (#8040217) |
| Address | 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, 2013, NZ |
| Mandatory US Agent | FISHER & PAYKEL LIMITED HEALTHCARE |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BTT |
| Regulation § (21 CFR) | 868.5450 |
| Proprietary names | Optiflow Oxygen Kit |
Source: openFDA. Public-domain (CC0).