SpeediCath Standard
Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag.
11manufacturers in China registered for this device type
47catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Coloplast A/S, Denmark |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2020-03-25 |
| Record revised | 2025-01-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Packaging | Shipper box of 100, retail box of 30, shipper box of 10 |
| Sizes | Catheter gauge 6 to 18 Fr; catheter working length 16 to 35 cm; catheter working length 6.3 to 13.9 in |
| Distribution end date | 2025-01-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28485 | Catheter Gauge 16 Fr | In distribution |
| 28500 | Catheter Gauge 8 Fr | In distribution |
| 28610 | Catheter Gauge 10 Fr | In distribution |
| 28416 | Catheter Gauge 16 Fr | In distribution |
| 28418 | Catheter Gauge 18 Fr | In distribution |
| 28482 | Catheter Gauge 10 Fr | In distribution |
| 28608 | Catheter Gauge 8 Fr | In distribution |
| 28501 | Catheter Gauge 10 Fr | In distribution |
| 28710 | Catheter Gauge 10 Fr | In distribution |
| 28508 | Catheter Gauge 8 Fr | In distribution |
| 28503 | Catheter Gauge 14 Fr | In distribution |
| 28612 | Catheter Gauge 12 Fr | In distribution |
| 28516 | Catheter Gauge 16 Fr | In distribution |
| 28514 | Catheter Gauge 14 Fr | In distribution |
| 28708 | Catheter Gauge 8 Fr | In distribution |
| 28706 | Catheter Gauge 6 Fr | In distribution |
| 28412 | Catheter Gauge 12 Fr | In distribution |
| 28606 | Catheter Gauge 6 Fr | In distribution |
| 28512 | Catheter Gauge 12 Fr | In distribution |
| 28510 | Catheter Gauge 10 Fr | In distribution |
| 28483 | Catheter Gauge 12 Fr | In distribution |
| 28490 | Catheter Gauge 10 Fr | In distribution |
| 28494 | Catheter Gauge 14 Fr | In distribution |
| 28408 | Catheter Gauge 8 Fr | In distribution |
| 28492 | Catheter Gauge 12 Fr | In distribution |
| 28414 | Catheter Gauge 14 Fr | In distribution |
| 28506 | Catheter Gauge 6 Fr | In distribution |
| 28484 | Catheter Gauge 14 Fr | In distribution |
| 28496 | Catheter Gauge 16 Fr | In distribution |
| 28502 | Catheter Gauge 12 Fr | In distribution |
| 28410 | Catheter Gauge 10 Fr | In distribution |
| 28499 | Catheter Gauge 6 Fr | In distribution |
| 28504 | Catheter Gauge 16 Fr | In distribution |
| 28481 | Catheter Gauge 8 Fr | In distribution |
| 28486 | Catheter Gauge 18 Fr | In distribution |
| 28483 | Catheter Gauge 12 Fr | Withdrawn |
| 28486 | Catheter Gauge 18 Fr | Withdrawn |
| 28504 | Catheter Gauge 16 Fr | Withdrawn |
| 28500 | Catheter Gauge 8 Fr | Withdrawn |
| 28484 | Catheter Gauge 14 Fr | Withdrawn |
| 28499 | Catheter Gauge 6 Fr | Withdrawn |
| 28503 | Catheter Gauge 14 Fr | Withdrawn |
| 28502 | Catheter Gauge 12 Fr | Withdrawn |
| 28485 | Catheter Gauge 16 Fr | Withdrawn |
| 28482 | Catheter Gauge 10 Fr | Withdrawn |
| 28481 | Catheter Gauge 8 Fr | Withdrawn |
| 28501 | Catheter Gauge 10 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BeneCath® | Hangzhou Jimushi Meditech Co., Ltd. | 57 |
| 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 |
| Teleflex | Teleflex Medical LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150935 | 2015-07-02 |
| K143182 | 2015-01-20 |
| K121458 | 2012-10-01 |
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.