Urocare® Male Urinal Kit, Velcro® Closue, Large
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGE Contains: 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex…
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGE Contains: 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
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 | 2018-04-11 |
| Record revised | 2024-10-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place away from direct sunlight |
| Sizes | Total volume 270 ml; total volume 9 Fluid Ounce; depth 1.63 in; weight 0.45 lb; width 5.63 in; height 9.25 in; circumference 40 mm; lumen/inner diameter 20 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4403 | Total Volume 270 ml | 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.