Chemosite
Low Profile Venous Access System,120026;120039
5manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | Covidien LP, 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 |
| 510(k) | K952748 |
| Record published | 2015-08-28 |
| Record revised | 2025-06-24 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 59 to 86 °F; Special storage condition: ; |
| Packaging | Case of 12 |
| Sizes | Outer diameter 0.038 to 2.8 mm; catheter gauge 7 to 9 Fr; total volume 12 ml |
| Distribution end date | 2020-11-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 120023A | Outer Diameter 2 mm | Withdrawn |
| 120066 | Outer Diameter 1.0 mm | Withdrawn |
| 120021 | Outer Diameter 2.5 mm | Withdrawn |
| 120010 | Withdrawn | |
| 120092 | Outer Diameter 1.0 mm | Withdrawn |
| 120025 | Outer Diameter 1.0 mm | Withdrawn |
| 120011 | Outer Diameter 1.0 mm | Withdrawn |
| 120039 | Needle Gauge,18,Gauge; | Withdrawn |
| 120089 | Outer Diameter.038 mm | Withdrawn |
| 120045 | Outer Diameter 1.3 mm | Withdrawn |
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 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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.