SpeediCath Compact
SpeediCath Compact Male Kit sample pack. Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 5 sterile catheters…
SpeediCath Compact Male Kit sample pack. Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 5 sterile catheters and 5 x non-sterile urine collection bag. Rx-only.
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 |
| 510(k) | K210250 |
| Record published | 2022-04-01 |
| Record revised | 2024-07-12 (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: Do not use if sterile barrier is damaged; Special storage condition: Keep away from sunlight |
| Packaging | Shipper box of 10, retail box of 30 |
| Sizes | Catheter gauge 10 to 18 Fr; outer diameter 3.3 to 6 mm; length 3.25 in; catheter length 34 cm; outer diameter 0.16 in; catheter length 13.2 in; catheter working length 30 cm; catheter working length 11.8 in |
| Distribution end date | 2024-07-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28702 | Descriptive Catheter Length Male | Withdrawn |
| 28702 | Catheter Gauge 18 Fr | Withdrawn |
| 28112 | Female | Withdrawn |
| 28110 | Outer Diameter 3.3 mm | Withdrawn |
| M7354N | Outer Diameter 6 mm | Withdrawn |
| 28692 | Outer catheter FR 18/6.0 mm | Withdrawn |
| 28114 | Outer Diameter 4.7 mm | Withdrawn |
| M7442N | Catheter Gauge 12 Fr | Withdrawn |
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
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.