Dover
Male External Catheter,Texas Style, Standard, 1"" (2.5 cm) Foam Strap
4manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Sterieoss Medical Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 1 |
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | EXJ |
| Device type | Device, Incontinence, Urosheath Type, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-30 |
| Record revised | 2025-12-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 144, pack_or_inner_pack of 10, case of 120, case of 500 |
| Sizes | Outer diameter 1 to 1.375 in; length 30 in |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8884730200 | Outer Diameter 1.375 in | In distribution | |
| 8884730300 | Outer Diameter 1 in | In distribution | |
| 8887600149 | Length 30 in | Withdrawn | |
| 8884730600 | Outer Diameter 1 in | Withdrawn | |
| 8884731300 | Outer Diameter 1.375 in | 12 | Withdrawn |
| 8884730398 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wellead Male External Catheter | Well Lead Medical Co., Ltd. | 21 |
| Dover | Cardinal Health 200, LLC | 4 |
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.