Chemosite
Low Profile Venous Access System
2manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| 510(k) | K952748 |
| Record published | 2015-08-28 |
| Record revised | 2025-06-24 (version 10) |
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 | Handling environment temperature up to 130 °F |
| Packaging | Case of 20 |
| Sizes | Outer diameter 0.035 to 2.8 mm; length 19 to 50 mm; total volume 12 ml; catheter gauge 9 Fr |
| Distribution end date | 2020-11-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 120072 | Length 32 mm | Withdrawn |
| 120013 | Length 25 mm | Withdrawn |
| 120050 | Outer Diameter 1.3 mm | Withdrawn |
| 120069 | Length 19 mm | Withdrawn |
| 120049 | Outer Diameter.035 mm | Withdrawn |
| 120041 | Length 50 mm | Withdrawn |
| 120082 | Length 32 mm | Withdrawn |
| 120020 | Outer Diameter 1.0 mm | Withdrawn |
| 120075 | Length 25 mm | Withdrawn |
| 120053 | Needle Gauge,22,Gauge; | Withdrawn |
| 120035 | Needle Gauge,20,Gauge; | Withdrawn |
| 120073 | Length 25 mm | Withdrawn |
| 120112 | Withdrawn | |
| 120076 | Length 32 mm | Withdrawn |
| 120022 | Outer Diameter 1.3 mm | Withdrawn |
| 120037 | Length 19 mm | Withdrawn |
| 120074 | Length 19 mm | Withdrawn |
| 120024 | Outer Diameter 1.0 mm | Withdrawn |
| 120085 | Outer Diameter 1.0 mm | Withdrawn |
| 120046 | Length 19 mm | Withdrawn |
| 120044 | Outer Diameter 1.3 mm | Withdrawn |
| 120027 | Outer Diameter 1.0 mm | Withdrawn |
| 120012 | Length 19 mm | Withdrawn |
| 120077 | Length 32 mm | Withdrawn |
| 120047 | Outer Diameter 1.0 mm | Withdrawn |
| 120068 | Length 25 mm | Withdrawn |
| 120026 | Outer Diameter 2.8 mm | Withdrawn |
| 120059 | Length 19 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dignity® | Medical Components Inc | 168 |
| Deltec | ICU Medical, Inc | 130 |
| NorPort Vascular Access Port | Norfolk Medical | 106 |
| BioFlo Vortex | AngioDynamics, Inc. | 60 |
| BioFlo Vortex | Navilyst Medical, Inc. | 59 |
| Dignity® MID-Sized CT Port | Medical Components Inc | 55 |
| TidalPort Vascular Access Port | Norfolk Medical | 52 |
| Pro-Fuse® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Mini CT Port | Medical Components Inc | 44 |
| Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port | Medical Components Inc | 29 |
| PRO-Fuse® | Medical Components Inc | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
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.