FDA Device Establishments · JSON-LD · Markdown
FEI 3011237704 · Manufacture Medical Device · Status: Active
| FEI Number | 3011237704 |
|---|---|
| Owner / Operator | ICU Medical, Inc. (#8020727) |
| Address | Olomoucka 306, Hranice Olomoucky Kraj, 753 01, CZ |
| Mandatory US Agent | ICU Medical, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BTO |
| Regulation § (21 CFR) | 868.5800 |
| Proprietary names | UniPerc Adjustable Flange Tracheostomy Tube; Portex; UniPerc PDT Kit; UniPerc Percutaneous Dilation Tracheostomy Kit |
Source: openFDA. Public-domain (CC0).