B.braun
4F Picc Single 50 Nitgold 80 CTS450-NG80
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 | B. Braun Interventional Systems, Inc., 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) | K083873 |
| Record published | 2015-07-26 |
| Record revised | 2022-11-02 (version 7) |
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 |
| Storage | Special storage condition: ROOM TEMP; Special storage condition: KEEP AWAY FROM SUNLIGHT.; Special storage condition: KEEP DRY |
| Sizes | Catheter gauge 4 to 6 Fr |
| Distribution end date | 2016-07-11 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 613405 | Length of guidewire : 80.000 CM | 5 | Withdrawn |
| 613407 | Catheter Gauge 5.00 Fr | 5 | Withdrawn |
| 613400 | Length of catheter : 50.000 CM | 5 | Withdrawn |
| 613401 | Catheter Gauge 5.00 Fr | 5 | Withdrawn |
| 613411 | Length of guidewire : 80.000 CM | 5 | Withdrawn |
| 613412 | Length of guidewire : 130.000 CM | 5 | Withdrawn |
| 613403 | Length of catheter : 55.000 CM | 5 | Withdrawn |
| 613402 | Length of guidewire : 130.000 CM | 5 | Withdrawn |
| 613408 | Length of catheter : 60.000 CM | 5 | Withdrawn |
| 613406 | Length of guidewire : 80.000 CM | 5 | Withdrawn |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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| PFM Medical, Inc | 510(k) number | 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 100 units | 2015-04-23 |
| PFM Medical, Inc | 510(k) number | 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 90 units | 2015-04-23 |
| PFM Medical, Inc | 510(k) number | 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 83 units | 2015-04-23 |
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.