Biowy Picc Catheter S Kit
The Biowy PICC Catheter S Kit provides peripheral access to the central venous system for short-term or long-term intravenous therapy, blood sampling and power injection of contrast media.…
The Biowy PICC Catheter S Kit provides peripheral access to the central venous system for short-term or long-term intravenous therapy, blood sampling and power injection of contrast media. It contains a sterile, single-use, open-ended polyurethane catheter with a radiopaque shaft and depth markings.
The kit includes a stylet to support catheter insertion, a torque adapter for handling and withdrawing the stylet, and a T-lock that secures the stylet and permits flushing. The catheter has a reverse taper, with the zero depth mark identifying its taper point.
Listed Item
PICC 4F Single Lumen Catheter S Kit
Catheter Configurations
The 4F single-lumen catheter has a 55 cm usable length; the 5F dual-lumen catheter has a 60 cm usable length. Contrast injection is limited to 5 mL per second and injector pressure must not exceed 300 psi.
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 | Biowy 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 |
| 510(k) | K192246 |
| Record published | 2021-05-24 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner box of 5, outer box of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PICC5DK-S | In distribution | |
| PICC4SK-S | 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 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192246 | 2020-04-30 |
| K173956 | 2018-05-21 |
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.