FDA Device Establishments · JSON-LD · Markdown
FEI 3012542015 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3012542015 |
|---|---|
| Owner / Operator | ICU Medical, Inc. (#8020727) |
| Address | Bijsterhuizen 22 - 08, Wijchen Gelderland, 6604 LD, NL |
| 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 | Portex BLUselect Tracheostomy Tube; Portex BLUselect Tracheostomy Inner Cannula; Portex BLUselect Suctionaid Tracheostomy Tube |
Source: openFDA. Public-domain (CC0).