Medline
Adapter,catheter/Syringe/Luer,sterile
15manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing | Zhejiang | Manufacturer | 17 |
Showing 12 of 15. All 15 manufacturers in China registered for Connector, Catheter
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | GCD |
| Device type | Connector, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Premarket notification | Exempt |
| Record published | 2021-01-13 |
| Record revised | 2024-05-16 (version 3) |
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: Store at Room Temp/Avoid excessive heat, Do Not Freeze |
| Packaging | Case of 100, mc of 1000, box of 100, pack of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND2219 | In distribution | |
| DYND12200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Silicone Penrose Drain Tube | Fortune Medical Instrument Corp. | 38 |
| Pleur-Evac | Teleflex Medical LLC | 26 |
| Silicone Flat Drain | Fortune Medical Instrument Corp. | 14 |
| Silicone Round Drain | Fortune Medical Instrument Corp. | 14 |
| Cook | Cook Incorporated | 14 |
| Silicone Round Drain Kit | Fortune Medical Instrument Corp. | 12 |
| Argyle | Cardinal Health | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 9 |
| Silicone Flat Drain Kit | Fortune Medical Instrument Corp. | 8 |
| Argyle | Cardinal Health 200, LLC | 8 |
| Silicone Endo-Drain Kit | Fortune Medical Instrument Corp. | 6 |
| Silicone Vac-Drain | Fortune Medical Instrument Corp. | 6 |
Showing 12 of 49. All products under Connector, Catheter
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 1 Case |
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.