Disposable IV Catheter
Shinva Ande’s Disposable IV Catheter family provides short-term peripheral access for fluid administration, blood sampling or blood-pressure monitoring. The range includes straight, closed…
Shinva Ande’s Disposable IV Catheter family provides short-term peripheral access for fluid administration, blood sampling or blood-pressure monitoring. The range includes straight, closed and needleless closed configurations, with safety and nonsafety versions.
The safety versions add passive needle shielding to reduce accidental needlestick exposure. Closed configurations are designed to keep blood inside the device during insertion and include extension tubing and a pinch clamp.
Access Components
Depending on configuration, the assembly includes a septum, one- or two-port Luer adapter and a needleless connector. Straight configurations have catheter-hub wings and a vent fitting. Shielding and closed fluid-path components belong to the selected version and are not universal across all models.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Shinva Ande Healthcare Apparatus Co., Ltd., China |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| 510(k) | K202060 |
| Record published | 2023-05-08 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 50, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IVC07-18 | In distribution | |
| IVC07-20 | In distribution | |
| IVC09-20 | In distribution | |
| IVC07-16 | In distribution | |
| IVC07-14 | In distribution | |
| IVC07-24 | In distribution | |
| IVC09-26 | In distribution | |
| IVC09-14 | In distribution | |
| IVC09-24 | In distribution | |
| IVC07-22 | In distribution | |
| IVC09-18 | In distribution | |
| IVC07-26 | In distribution | |
| IVC09-16 | In distribution | |
| IVC09-22 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202060 | 2021-07-23 |
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.