Medline Industries, Inc.
KIT Manifold Cstm - River City
13manufacturers in China registered for this device type
62catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| 510(k) | K915301 |
| Record published | 2018-08-28 |
| Record revised | 2022-06-17 (version 5) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 15, case of 10, case of 300, case of 8750, case of 25, case of 40 |
| Distribution end date | 2021-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CDS985003A | In distribution | |
| SAMPC0129 | In distribution | |
| SAMPC0159 | In distribution | |
| DYKM1267 | In distribution | |
| SAMPC0317 | In distribution | |
| VASC1189 | In distribution | |
| SAMPC0313 | In distribution | |
| DYNJZ81205 | In distribution | |
| SAMPC0538 | In distribution | |
| DYKM1189 | In distribution | |
| DYNJMAN32 | In distribution | |
| VASC1200 | In distribution | |
| VASC1188 | In distribution | |
| 656608747 | In distribution | |
| SAMPC0132 | In distribution | |
| VASC1044 | In distribution | |
| DYNJ45161B | In distribution | |
| DYNJZ91628 | In distribution | |
| DYNJSC303 | In distribution | |
| DYNJ43119 | In distribution | |
| DYNJZ90127 | In distribution | |
| VASC1183 | In distribution | |
| DYNJZ90128 | In distribution | |
| DYNJZ91622 | In distribution | |
| DYKM1090 | In distribution | |
| SAMPC0156 | In distribution | |
| DYNJ54344D | In distribution | |
| SAMPC0151 | In distribution | |
| SAMPC0182 | In distribution | |
| SAMPC0166 | In distribution | |
| SAMPC0604 | In distribution | |
| DYNJ49008 | In distribution | |
| VASC1066 | In distribution | |
| SAMPC0535 | In distribution | |
| SAMPC0294 | In distribution | |
| ART1055 | In distribution | |
| VASC1074 | In distribution | |
| VASC1198 | In distribution | |
| DYNJMAN01 | In distribution | |
| SAMPC0609 | In distribution | |
| VASC1067 | In distribution | |
| SAMPC0569 | In distribution | |
| DYK100MRSA | In distribution | |
| VASC1062 | In distribution | |
| VASC1018A | In distribution | |
| VASC1061 | In distribution | |
| SAMPC0329 | In distribution | |
| SAMPC0172 | In distribution | |
| SAMPC0568 | In distribution | |
| SAMPC0187 | In distribution | |
| VASC1182 | In distribution | |
| SAMPC0173 | In distribution | |
| 125722 | In distribution | |
| CDS985003 | In distribution | |
| VASC1064 | In distribution | |
| SAMPC0551 | In distribution | |
| SAMPC0161 | In distribution | |
| SAMPC0165 | In distribution | |
| SAMPC0522 | Withdrawn | |
| SAMPC0525 | Withdrawn | |
| SAMPC0530 | Withdrawn | |
| SAMPC0523 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Medline Industries, Inc. | 170 |
| Namic | Navilyst Medical, Inc. | 165 |
| Merit® Manifold | Merit Medical Systems, Inc. | 119 |
| Connector | LivaNova USA, Inc. | 70 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 60 |
| DLP® | Medtronic, Inc. | 51 |
| Marquis® Stopcock | Merit Medical Systems, Inc. | 40 |
| Cook | Cook Incorporated | 38 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| Contrast Line | Argon Medical Devices, Inc. | 25 |
| INT | Shanghai Kindly Medical Instruments Co., Ltd. | 18 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120069 | 2012-04-03 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class I | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | 1698 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 58836 units |
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.