Teleflex
RUSCH MMG H2O Kit: Hydrophilic closed-system intermittent catheter
11manufacturers in China registered for this device type
22catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (6), Jiangsu (4), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
| Hangzhou Bever Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 3 |
| Xianju JF Medister Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K183461 |
| Record published | 2026-04-10 |
| Record revised | 2023-07-18 (version 4) |
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, manufacturing date |
| Packaging | Case of 100 |
| Sizes | Outer diameter 2 to 5.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20096160 | Outer Diameter 5.3 mm | In distribution |
| IPN050782 | Outer Diameter 4 mm | In distribution |
| IPN050786 | Outer Diameter 5.3 mm | In distribution |
| 21096080 | Outer Diameter 2.7 mm | In distribution |
| 21096140 | Outer Diameter 4.7 mm | In distribution |
| 21096100 | Outer Diameter 3.3 mm | In distribution |
| IPN050843 | Outer Diameter 4.7 mm | In distribution |
| 20096060 | Outer Diameter 2.0 mm | In distribution |
| IPN050844 | Outer Diameter 5.3 mm | In distribution |
| IPN050784 | Outer Diameter 4.7 mm | In distribution |
| IPN050841 | Outer Diameter 3.3 mm | In distribution |
| 20096140 | Outer Diameter 4.7 mm | In distribution |
| 20096120 | Outer Diameter 4.0 mm | In distribution |
| 20096080 | Outer Diameter 2.7 mm | In distribution |
| IPN050842 | Outer Diameter 4 mm | In distribution |
| IPN050840 | Outer Diameter 2.7 mm | In distribution |
| 20096100 | Outer Diameter 3.3 mm | In distribution |
| IPN050780 | Outer Diameter 3.3 mm | In distribution |
| IPN050778 | Outer Diameter 2.7 mm | In distribution |
| IPN050776 | Outer Diameter 2 mm | In distribution |
| 21096160 | Outer Diameter 5.3 mm | In distribution |
| 21096120 | Outer Diameter 4.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BeneCath® | Hangzhou Jimushi Meditech Co., Ltd. | 57 |
| SpeediCath Standard | Coloplast A/S | 47 |
| TruCath | HR Pharmaceuticals Inc. | 46 |
| VaPro | Hollister Incorporated | 31 |
| Actreen® | B. Braun Medical Inc. | 28 |
| McKesson | Mckesson Medical-Surgical Inc. | 25 |
| BD Intermittent | Hangzhou Bever Medical Devices Co., Ltd. | 24 |
| Gentlecath AIR | Convatec, Purchasing Department | 24 |
| VaPro Pocket | Hollister Incorporated | 23 |
| Apogee | Hollister Incorporated | 23 |
| Dover | Cardinal Health | 23 |
| Dover | Cardinal Health 200, LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-15 | Class II | Employee error | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. | 4220 units | 2020-10-05 |
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.