Mongoose
41 catalogue numbers from A-3JB1-80/0045, listed by Togo Medikit Co., Ltd., Japan, under Catheter, Intravascular, Diagnostic. 11 manufacturers in China are registered for this product code.
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 | Togo Medikit Co., Ltd., Japan |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K113819 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store this product in a cool, dark, dry place. |
| Packaging | Carton of 10, box of 3, box of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-3JB1-80/0045 | 80cm Length | In distribution |
| A-3JB1-60/0044 | 3.3Fr Catheter diameter | In distribution |
| A-4JR1-80/0017 | 4.0Fr Catheter diameter | In distribution |
| A-3COB-80/0039 | 3.3Fr Catheter diameter | In distribution |
| A-5MP-80/0037 | 5.0Fr Catheter diameter | In distribution |
| A-4JB1-60/0010 | 4.0Fr Catheter diameter | In distribution |
| A-4MP-80/0035 | 4.0Fr Catheter diameter | In distribution |
| A-3JB1-80/0009 | 3.3Fr Catheter diameter | In distribution |
| A-4JLA-80/0029 | 80cm Length | In distribution |
| A-4JL1-60/0022 | 60cm Length | In distribution |
| A-3COB-60/0038 | 3.3Fr Catheter diameter | In distribution |
| A-5PIG-80/0007 | 5.0Fr Catheter diameter | In distribution |
| A-5JL1-60/0024 | 60cm Length | In distribution |
| A-3PIG-40/0001 | 40cm Length | In distribution |
| A-4PIG-60/0004 | 4.0Fr Catheter diameter | In distribution |
| A-3JLA-80/0027 | 80cm Length | In distribution |
| A-5COB-80/0043 | 80cm Length | In distribution |
| A-5JR1-80/0019 | 80cm Length | In distribution |
| A-4COB-60/0040 | 60cm Length | In distribution |
| A-4JR1-60/0016 | 60cm Length | In distribution |
| A-3JR2-60/0046 | 60cm Length | In distribution |
| A-5JB1-80/0013 | 80cm Length | In distribution |
| A-5JL1-80/0025 | 5.0Fr Catheter diameter | In distribution |
| A-3MP-60/0032 | 3.3Fr Catheter diameter | In distribution |
| A-3PIG-80/0003 | 3.3Fr Catheter diameter | In distribution |
| A-4MP-60/0034 | 60cm Length | In distribution |
| A-3JLA-60/0026 | 60cm Length | In distribution |
| A-3JR1-60/0014 | 3.3Fr Catheter diameter | In distribution |
| A-3JL1-80/0021 | 3.3Fr Catheter diameter | In distribution |
| A-3JL1-60/0020 | 3.3Fr Catheter diameter | In distribution |
| A-4JL1-80/0023 | 4.0Fr Catheter diameter | In distribution |
| A-5PIG-60/0006 | 60cm Length | In distribution |
| A-3PIG-60/0002 | 3.3Fr Catheter diameter | In distribution |
| A-4PIG-80/0005 | 4.0Fr Catheter diameter | In distribution |
| A-3JB1-60/0008 | 3.3Fr Catheter diameter | In distribution |
| A-4JB1-80/0011 | 4.0Fr Catheter diameter | In distribution |
| A-3JR1-80/0015 | 80cm Length | In distribution |
| A-4JLA-60/0028 | 4.0Fr Catheter diameter | In distribution |
| A-3JR2-80/0047 | 3.3Fr Catheter diameter | In distribution |
| A-3MP-80/0033 | 3.3Fr Catheter diameter | In distribution |
| A-4COB-80/0041 | 80cm Length | 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
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.