FDA Device Establishments · JSON-LD · Markdown
FEI 3008264065 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3008264065 |
|---|---|
| Owner / Operator | FISHER & PAYKEL HEALTHCARE NZ LTD (#8040217) |
| Address | Av. Todos los Santos #12831, Parque Industrial Pacifico, Tijuana Baja California, 22643, MX |
| Mandatory US Agent | FISHER & PAYKEL LIMITED HEALTHCARE |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BYG |
| Regulation § (21 CFR) | 868.5580 |
| Proprietary names | FlexiFit 407 (Sleep Lab); FlexiFit 405 (Sleep Lab); FlexiFit 407; Mask Oxygen |
Source: openFDA. Public-domain (CC0).