Synergy
5Fr x 60cm Single Lumen Synergy CT PICC Nursing Kit
5manufacturers in China registered for this device type
53catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Health Line International Corporation, United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K101329 |
| Record published | 2016-03-31 |
| Record revised | 2023-05-24 (version 6) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner of 5, carton of 4, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A14-06360 | In distribution | |
| A14-06260 | In distribution | |
| A14-05260-IR | In distribution | |
| A14-06360-03 | In distribution | |
| A14-06260-N | In distribution | |
| A14-04160-IR | In distribution | |
| A14-05260-IR-03 | In distribution | |
| A14-06260-IR | In distribution | |
| A14-05160-N | In distribution | |
| A14-05255-IR | In distribution | |
| A14-04160-IR-03 | In distribution | |
| A14-05255 | In distribution | |
| KIT-400-41 | In distribution | |
| KIT-400-63 | In distribution | |
| KIT-410-62 | In distribution | |
| A14-06360-N | In distribution | |
| A14-05260-03 | In distribution | |
| KIT-405-62 | In distribution | |
| KIT-400-51 | In distribution | |
| A14-06260-IR-03 | In distribution | |
| A14-05160-IR-03 | In distribution | |
| A14-05160 | In distribution | |
| KIT-400-52 | In distribution | |
| KIT-405-51 | In distribution | |
| A14-05160-N-03 | In distribution | |
| KIT-405-41 | In distribution | |
| A14-04260 | In distribution | |
| A14-05255-N | In distribution | |
| A14-05160-03 | In distribution | |
| A14-04160-03 | In distribution | |
| KIT-410-52 | In distribution | |
| A14-04150 | In distribution | |
| A14-05155-IR | In distribution | |
| A14-05155 | In distribution | |
| A14-05260-N | In distribution | |
| A14-05260-N-03 | In distribution | |
| A14-04160-N | In distribution | |
| A14-06260-03 | In distribution | |
| A14-04160 | In distribution | |
| A14-06260-N-03 | In distribution | |
| KIT-410-51 | In distribution | |
| A14-06360-N-03 | In distribution | |
| A14-05260 | In distribution | |
| A14-06360-IR-03 | In distribution | |
| A14-04150-IR | In distribution | |
| A14-04160-N-03 | In distribution | |
| KIT-400-62 | In distribution | |
| KIT-405-63 | In distribution | |
| KIT-405-52 | In distribution | |
| KIT-410-41 | In distribution | |
| A14-05155-N | In distribution | |
| A14-05160-IR | In distribution | |
| A14-06360-IR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Vygon | Vygon Corp. | 50 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130034 | 2013-03-08 |
| K101329 | 2010-08-19 |
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.