175IBLSSC
Catheter Injection port
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
Record
| Listed by | Elcam Medical Italy SPA, Italy |
|---|---|
| FDA product code | GCE |
| Device type | Adaptor, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Manufacturer |
| 510(k) | K855039 |
| Record published | 2019-02-26 |
| Record revised | 2025-08-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 1000, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 175IBLSSC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| ICU Medical | ICU Medical, Inc | 2 |
| Cook | Cook Incorporated | 2 |
| Addto | Addto, Inc. | 1 |
| Maveric Medical | Maveric Medical LLC | 1 |
| CLR Port Cap | CLR Medical Inc. | 1 |
| Cardiothoracic Adaptor | C.R. Bard, Inc. | 1 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 1 |
| CLR Port Injector | CLR Medical Inc. | 1 |
| CLR Port | CLR Medical Inc. | 1 |
| Maveric Medical LLC | Maveric Medical LLC | 1 |
| RPC | Reprocessing Products Corp | 1 |
Showing 12 of 14. All products under Adaptor, Catheter
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.