GentleCath Hydrophilic Kit
Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 16FR
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Ningbo Jenius Polymer SCI-Tech Co., Ltd. | Yinzhou District, Ningbo | Zhejiang | Manufacturer | 29 |
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Wellspect Healthcare, Sweden |
|---|---|
| FDA product code | EYY |
| Device type | Drape, Urological, Disposable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2024-06-01 |
| Record revised | 2024-12-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry |
| Packaging | Pack of 10, pack of 4 |
| Sizes | Length 8 to 16 in; catheter gauge 10 to 16 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 509008 | Length 8 in | In distribution |
| 509018 | Length 16 in | In distribution |
| 509005 | Catheter Gauge 10 Fr | In distribution |
| 509013 | Length 16 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Convertors | Cardinal Health 200, LLC | 20 |
| SimPro™ Set | Wellspect Healthcare | 3 |
| Cardinal Health | Cardinal Health 200, LLC | 3 |
| Lithotomy Drape | Procept BioRobotics Corporation | 3 |
| Essential Drape 1PK | Procept BioRobotics Corporation | 1 |
| Aquablation Therapy® | Microtek Medical LLC | 1 |
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.