TidalPort Vascular Access Port
Low-Profile Titanium TidalPort Vascular Access Port with 5F preattached Polyurethane Catheter and Standard Introducer Kit
2manufacturers in China registered for this device type
52catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Norfolk Medical, United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Record published | 2015-09-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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, manufacturing date |
| Sizes | Total volume 0.183 to 0.53 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.333 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.183 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
| TidalPort | Total Volume 0.53 ml | In distribution |
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 |
| 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 |
| Xcela | Navilyst Medical, Inc. | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111101 | 2011-08-25 |
| K905646 | 1991-03-27 |
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.