Tidal High-Flow Non-Coring Needle
The Tidal High Flow Noncoring Needle accesses a totally implantable vascular access port for intravenous therapy. It supports delivery of fluids, drugs, blood or blood products and…
The Tidal High Flow Noncoring Needle accesses a totally implantable vascular access port for intravenous therapy. It supports delivery of fluids, drugs, blood or blood products and withdrawal of blood as part of a treatment regimen.
The 16 and 18 gauge needles use a stylet to provide the noncoring design. The needle is made from 304 series stainless steel, with molded K Resin and low density polyethylene hub components.
Listed Item
18G x 1-1/4″ Tidal High-Flow Non-coring Needle
Sterile Single Use Supply
Each disposable needle is packaged in a single use peel pouch and supplied sterile and nonpyrogenic. Sterilization uses ethylene oxide. The needle serves as the access component for an implanted port, with the port itself remaining a separate device.
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Norfolk Medical, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K151341 |
| Record published | 2015-10-06 |
| Record revised | 2019-10-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Sizes | Needle gauge 16 to 18 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Tidal-HF | Needle Gauge 16 G | In distribution |
| Tidal-HF | Needle Gauge 18 G | In distribution |
| Tidal-HF | Needle Gauge 16 G | In distribution |
| Tidal-HF | Needle Gauge 16 G | In distribution |
| Tidal-HF | Needle Gauge 18 G | In distribution |
| Tidal-HF | Needle Gauge 18 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151341 | 2015-08-20 |
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.