Bard® T-Tube
Whelan-Moss T-Tubes
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | PTT |
| Device type | Biliary Catheter For Irrigation And Contrast Injection, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-10-12 |
| Record revised | 2020-11-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0103220 | In distribution | |
| 0103250 | In distribution | |
| 0103240 | In distribution | |
| 0103230 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Silicone T-Tube | Bentec Medical OpCo, LLC. | 11 |
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.