FDA Device Establishments · JSON-LD · Markdown
FEI 3003348376 · Manufacture Medical Device · Status: Active
| FEI Number | 3003348376 |
|---|---|
| Owner / Operator | GIVEN IMAGING INC. (#10091555) |
| Address | 2 Hacarmel St., NEW INDUSTRIAL Park, POB 258, Yoqneam Northern, 20692, IL |
| Mandatory US Agent | Medtronic, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FFT |
| Regulation § (21 CFR) | 876.1400 |
| Proprietary names | Versaflex pH Z catheters; Versaflex pH catheters; pHersaflex pH catheters; Reflux software; Digitrapper pH Z; AccuView pH & pH-Z software |
Source: openFDA. Public-domain (CC0).