Langston
Langston V2 6F Pigtail 5 Marker Band
11manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-11-08 |
| Record revised | 2022-09-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5, pack of 5 |
| Sizes | Catheter gauge 6 to 7 Fr; angle 145 °; length 110 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN913558 | Angle 145 ° | In distribution |
| IPN930135 | In distribution | |
| IPN913560 | Catheter Gauge 6 Fr | In distribution |
| IPN913559 | Angle 145 ° | In distribution |
| IPN930562 | In distribution | |
| IPN939019 | In distribution | |
| IPN923473 | Catheter Gauge 6 Fr | In distribution |
| IPN913561 | Catheter Gauge 6 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vascular Solutions LLC | UDI-DI | 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 1,680 units | 2024-06-18 |
| Vascular Solutions LLC | UDI-DI | 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 89,121 units | 2024-06-18 |
| Vascular Solutions LLC | UDI-DI | 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 1,745 units | 2024-06-18 |
| Vascular Solutions LLC | UDI-DI | 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 2990 units | 2024-06-18 |
| Vascular Solutions LLC | UDI-DI | 2020-03-16 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 30,877 units | 2024-06-18 |
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.