Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50
Urofoam®-1 single-sided adhesive foam strips are soft, pliable foam strips specifically designed for the unique application of male external catheters to the body and are suitable for use…
Urofoam®-1 single-sided adhesive foam strips are soft, pliable foam strips specifically designed for the unique application of male external catheters to the body and are suitable for use with both standard and self-adhering type catheters. They provide a comfortable, effective way to secure a male external catheter to the body. They are easy to apply and remove so when it comes time to change that catheter, it can be changed easily and quickly. It is recommended that a male external catheter be changed once a day to promote healthy skin, however, with the use or Urofoam® strips, a male external catheter can be held in place for up to three days → results may vary, but it’s nice to know that when you need to depend on an adhesive strip, you can depend on Urofoam®.
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Taicang Yigao Medical Technology Co., Ltd. | Taicang | Jiangsu | Manufacturer | 20 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
Showing 12 of 13. All 13 manufacturers in China registered for Device, Incontinence, Urosheath Type, Non-Sterile
Record
| Listed by | Urocare Products, Inc., United States |
|---|---|
| FDA product code | NNX |
| Device type | Device, Incontinence, Urosheath Type, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-30 |
| Record revised | 2022-11-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in cool, dark, dry place. |
| Sizes | Weight 0.18 lb |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5100 | 0.09″ x 0.88″ x 5.75″ (0.3cm x 2.2cm x 14.6cm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clear Advantage Male Continence Sheath | C.R. Bard, Inc. | 40 |
| Spirit® Hydrocolloid Adhesive Sheath | C.R. Bard, Inc. | 30 |
| Aurora Hydrocolloide Adhesive Sheath | C.R. Bard, Inc. | 15 |
| Transfix Continence Sheath | C.R. Bard, Inc. | 15 |
| Freedom Clear | Coloplast A/S | 14 |
| UltraFlex™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Freedom Clear Advantage | Coloplast A/S | 10 |
| InView Extra | Hollister Incorporated | 10 |
| Wideband™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Clear Advantage Spirit Adhesive Sheath | C.R. Bard, Inc. | 10 |
| Pop-On™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| InView Standard | Hollister Incorporated | 10 |
Showing 12 of 86. All products under Device, Incontinence, Urosheath Type, Non-Sterile
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.