Transit-Pellets
Transit-Pellets are swallowed radiopaque markers used to evaluate colonic transit in adults with chronic constipation. An abdominal radiograph shows how many markers remain and where they…
Transit-Pellets are swallowed radiopaque markers used to evaluate colonic transit in adults with chronic constipation. An abdominal radiograph shows how many markers remain and where they are located in the colon, providing information used to calculate transit time and distinguish slow from normal transit.
The markers are supplied in cellulose capsules for a sequence of doses over six days, followed by imaging on day seven. Their positions support assessment of total colonic transit and transit through individual segments. The package is intended for a single patient.
Listed Item
Transit-Pellets radiopaque markers.
Marker Construction
The ring-shaped and tube-shaped markers contain 22 percent barium sulfate and 78 percent silicone rubber. The barium-containing material makes the markers visible on X-ray images. They are supplied nonsterile for prescription use.
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 | Medifactia AB, Sweden |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| 510(k) | K181760 |
| Record published | 2019-10-09 |
| Record revised | 2024-04-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Stored at normal room temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Radiopaque Markers | In distribution |
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 |
|---|---|
| K222000 | 2023-01-18 |
| K181760 | 2019-08-08 |
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.