Actreen®
Actreen® Hi-Lite Cath Straight Set 37cm 18 Fr
11manufacturers in China registered for this device type
28catalogue 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 | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-03-03 |
| Record revised | 2025-08-25 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: This way up; Special storage condition: KEEP DRY; Special storage condition: Keep away from sunlight |
| Packaging | Carton of 16, carton of 14, carton of 18, carton of 56 |
| Sizes | Outer diameter 2.7 to 6 mm; catheter gauge 8 to 18 Fr; length 9 to 41 cm |
| Distribution end date | 2021-07-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 238208NA | Charrière (catheter) : 8.000 | 30 | Withdrawn |
| 242116NA | Length 37 cm | 30 | Withdrawn |
| 238108NA | Catheter Gauge 8.0 Fr | 30 | Withdrawn |
| 239014NA | Length 9.0 cm | 30 | Withdrawn |
| 228012NA | Charrière (catheter) : 12.000 | 30 | Withdrawn |
| 238214NA | Outer Diameter 4.7 mm | 30 | Withdrawn |
| 238218NA | Outer Diameter 6.0 mm | 30 | Withdrawn |
| 238114NA | Catheter Gauge 14.0 Fr | 30 | Withdrawn |
| 242218NA | Outer Diameter 6.0 mm | 30 | Withdrawn |
| 238118NA | Outer Diameter 6.0 mm | 30 | Withdrawn |
| 242210NA | Charrière (catheter) : 10.000 | 30 | Withdrawn |
| 238116NA | Charrière (catheter) : 16.000 | 30 | Withdrawn |
| 238216NA | Outer Diameter 5.3 mm | 30 | Withdrawn |
| 239012NA | Outer Diameter 4.0 mm | 30 | Withdrawn |
| 238210NA | Outer Diameter 3.3 mm | 30 | Withdrawn |
| 238110NA | Charrière (catheter) : 10.000 | 30 | Withdrawn |
| 242214NA | Catheter Gauge 14.0 Fr | 30 | Withdrawn |
| 242110NA | Charrière (catheter) : 10.000 | 30 | Withdrawn |
| 242212NA | Length 37 cm | 30 | Withdrawn |
| 239010NA | Outer Diameter 3.3 mm | 30 | Withdrawn |
| 242118NA | Length 37 cm | 30 | Withdrawn |
| 242114NA | Catheter Gauge 14.0 Fr | 30 | Withdrawn |
| 238212NA | Catheter Gauge 12.0 Fr | 30 | Withdrawn |
| 228010NA | Catheter Gauge 10.0 Fr | 30 | Withdrawn |
| 242112NA | Outer Diameter 4.0 mm | 30 | Withdrawn |
| 238112NA | Length 41.0 cm | 30 | Withdrawn |
| 228014NA | Charrière (catheter) : 14.000 | 30 | Withdrawn |
| 242216NA | Outer Diameter 5.3 mm | 30 | 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 |
| 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 |
|---|---|
| K192577 | 2020-05-07 |
| K180801 | 2018-11-05 |
| K151772 | 2016-02-09 |
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.