FDA Device Establishments · JSON-LD · Markdown
FEI 3012543139 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3012543139 |
|---|---|
| Owner / Operator | Medline Industries, LP (#1417592) |
| Address | Medline Strasse 1-3, Kleve North Rhine-Westphalia, 47533, DE |
| Mandatory US Agent | Simcon International LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OGG |
| Regulation § (21 CFR) | 868.5450 |
| Proprietary names | Comfort Flo Humidification System; Hudson RCI Conventional Breathing Circuit with Nebulizer; Hudson RCI Circuit / Column Kits; Medline Humidifier Nebulizer Kit; ISO GARD Breathing Circuit Kit; Aquapak Humidifier Reservoir with Adaptor; Gibeck Humid-Flo and Passive Kits; Hudson RCI Conventional Breathing Circuit with Filter; Aquapak Nebulizer Reservoir with Adaptor; Oxygen Therapy Start-Up Kit |
Source: openFDA. Public-domain (CC0).