BD Intermittent
BD Ready-To-Use Hydrophilic Catheter
11manufacturers in China registered for this device type
24catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Hangzhou Bever Medical Devices Co., Ltd., China |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K192468 |
| Record published | 2021-01-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Away from Sunlight and Keep Dry.; Storage environment temperature 32 to 140 °F |
| Packaging | Case of 30, box of 270, box of 300 |
| Sizes | Catheter gauge 6 to 16 Fr; catheter length 6.3 to 16 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RTU16M | Catheter Gauge 16 Fr | In distribution |
| RTU12F | Catheter Gauge 12 Fr | In distribution |
| BUC10F | Catheter Gauge 10 Fr | In distribution |
| BUC12F | Catheter Gauge 12 Fr | In distribution |
| RTU12M | Catheter Gauge 12 Fr | In distribution |
| RTU14C | Catheter Gauge 14 Fr | In distribution |
| RTU08P | Catheter Gauge 8 Fr | In distribution |
| RTU10P | Catheter Gauge 10 Fr | In distribution |
| BUC10P | Catheter Gauge 10 Fr | In distribution |
| BUC06P | Catheter Gauge 6 Fr | In distribution |
| BUC14M | Catheter Gauge 14 Fr | In distribution |
| RTU12C | Catheter Gauge 12 Fr | In distribution |
| RTU14M | Catheter Gauge 14 Fr | In distribution |
| RTU06P | Catheter Gauge 6 Fr | In distribution |
| RTU10F | Catheter Gauge 10 Fr | In distribution |
| BUC14F | Catheter Gauge 14 Fr | In distribution |
| BUC12M | Catheter Gauge 12 Fr | In distribution |
| BUC16C | Catheter Gauge 16 Fr | In distribution |
| BUC08P | Catheter Gauge 8 Fr | In distribution |
| BUC14C | Catheter Gauge 14 Fr | In distribution |
| BUC12C | Catheter Gauge 12 Fr | In distribution |
| BUC16M | Catheter Gauge 16 Fr | In distribution |
| RTU14F | Catheter Gauge 14 Fr | In distribution |
| RTU16C | Catheter Gauge 16 Fr | 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 |
| 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 |
| Teleflex | Teleflex Medical LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192468 | 2019-11-27 |
| K111405 | 2012-02-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Hangzhou Bever Medical Devices Co., Ltd. | 510(k) number | 2025-11-29 | Class II | Labeling Change Control | Labeling error, Incorrect expiration date | 149310 units |
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.