pHTip Disposable Catheter
5 catalogue numbers from K6011-EI-0634, listed by Unisensor AG, United States, under System, Gastrointestinal Motility (Electrical). 1 manufacturer in China is registered for this product code.
1manufacturer
5catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Medical Technologies (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| Listed by | Unisensor AG, United States |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| Record published | 2016-09-19 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Sizes | Catheter gauge 6 Fr |
| Distribution end date | 2017-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K6011-EI-0634 | Catheter Gauge 6 Fr | In distribution |
| K6011-EI-0782 | Catheter Gauge 6 Fr | In distribution |
| K6011-EI-0632 | Catheter Gauge 6 Fr | In distribution |
| K6011-EI-0633 | Catheter Gauge 6 Fr | In distribution |
| K6011-I-0731 | Catheter Gauge 6 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mui Scientific | H&A Mui Enterprises, Inc. | 771 |
| UniTip High Resolution Catheter | Unisensor AG | 183 |
| UniTip Catheter | Unisensor AG | 100 |
| ManoScan | Given Imaging Ltd. | 60 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 27 |
| inSIGHT Ultima | Diversatek Healthcare Inc | 19 |
| Endoflip | Covidien LP | 17 |
| Sitzmarks Radiopaque Markers | Konsyl Pharmaceuticals, Inc. | 14 |
| Zvu® | Diversatek Healthcare Inc | 11 |
| Distender II Barostat | G & J Electronics, Inc. | 9 |
| PriZm | Diversatek Healthcare Inc | 8 |
| ManoView | Given Imaging Ltd. | 6 |
Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062222 | 2007-03-15 |
| K003580 | 2001-07-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.