Arrow
14 Ga. x 8" (20 cm) Radiopaque Polyurethane Indwelling Catheter with Side Holes
60manufacturers in China registered for this device type
94catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K781978 |
| Record published | 2017-12-01 |
| Record revised | 2024-02-12 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C; Special storage condition: Store between 20 – 25°C (68 – 77°F). |
| Packaging | Case of 10, box of 25, case of 25, case of 20, case, multipack of 25 |
| Sizes | Length 0 cm; catheter length 8 in |
| Distribution end date | 2025-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN033854 | In distribution | |
| IPN039887 | In distribution | |
| IPN035636 | In distribution | |
| IPN036241 | In distribution | |
| IPN035384 | In distribution | |
| IPN036889 | In distribution | |
| IPN032623 | In distribution | |
| IPN035753 | In distribution | |
| IPN033852 | In distribution | |
| IPN040172 | Length 0 cm | In distribution |
| IPN914820 | In distribution | |
| IPN040169 | In distribution | |
| IPN036240 | In distribution | |
| IPN919239 | In distribution | |
| IPN036239 | In distribution | |
| IPN040171 | In distribution | |
| IPN920398 | In distribution | |
| IPN036102 | In distribution | |
| IPN917018 | In distribution | |
| IPN040173 | In distribution | |
| IPN917019 | In distribution | |
| IPN915240 | In distribution | |
| IPN040171 | In distribution | |
| IPN039974 | In distribution | |
| IPN033852 | In distribution | |
| IPN032887 | In distribution | |
| IPN036856 | In distribution | |
| IPN036902 | In distribution | |
| IPN033854 | In distribution | |
| IPN036236 | In distribution | |
| IPN919521 | In distribution | |
| IPN919502 | In distribution | |
| IPN032630 | In distribution | |
| IPN032624 | In distribution | |
| IPN054778 | In distribution | |
| IPN040173 | In distribution | |
| IPN032629 | In distribution | |
| IPN035709 | In distribution | |
| IPN915669 | In distribution | |
| IPN035719 | In distribution | |
| IPN036265 | In distribution | |
| IPN032622 | In distribution | |
| IPN928619 | In distribution | |
| IPN918707 | In distribution | |
| IPN918702 | In distribution | |
| IPN919241 | In distribution | |
| IPN035385 | In distribution | |
| IPN914815 | In distribution | |
| IPN036234 | In distribution | |
| IPN036237 | In distribution | |
| IPN915617 | Catheter Length 8 in | In distribution |
| IPN033138 | In distribution | |
| IPN040170 | Length 0 cm | In distribution |
| IPN033137 | In distribution | |
| IPN920397 | In distribution | |
| IPN036235 | In distribution | |
| IPN033850 | In distribution | |
| IPN035636 | In distribution | |
| IPN036246 | In distribution | |
| IPN920399 | In distribution | |
| IPN040172 | Length 0 cm | In distribution |
| IPN035722 | In distribution | |
| IPN039902 | In distribution | |
| IPN037084 | In distribution | |
| IPN036267 | In distribution | |
| IPN037106 | In distribution | |
| IPN033856 | In distribution | |
| IPN040168 | Length 0 cm | In distribution |
| IPN914736 | In distribution | |
| IPN919576 | In distribution | |
| IPN036233 | In distribution | |
| IPN032621 | In distribution | |
| IPN036245 | In distribution | |
| IPN036902 | In distribution | |
| IPN036889 | In distribution | |
| IPN036877 | In distribution | |
| IPN035645 | In distribution | |
| IPN035646 | In distribution | |
| IPN033851 | In distribution | |
| IPN035721 | In distribution | |
| IPN036856 | In distribution | |
| IPN032888 | In distribution | |
| IPN039968 | In distribution | |
| IPN040170 | Length 0 cm | In distribution |
| IPN928618 | In distribution | |
| IPN039977 | In distribution | |
| IPN039980 | In distribution | |
| IPN039972 | In distribution | |
| IPN039990 | In distribution | |
| IPN928617 | In distribution | |
| IPN919516 | In distribution | |
| IPN035754 | In distribution | |
| IPN039989 | In distribution | |
| IPN914819 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
| Integra® | Integra Pain Management | 77 |
Showing 12 of 913. All products under Syringe, Piston
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 35,540 |
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.