Wealy
The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It…
The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (2), Shanghai (1). 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 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Shantou Wealy Medical Instrument Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 10 |
| Jiangsu Kangbao Medical Equipment Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Micsafe Medical Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 9 |
Showing 12 of 13. All 13 manufacturers in China registered for Enteral Syringes With Enteral Specific Connectors
Record
| Listed by | Shantou Wealy Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | PNR |
| Device type | Enteral Syringes With Enteral Specific Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K203613 |
| Record published | 2022-10-13 |
| Record revised | 2022-12-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 60, carton of 4, box of 80, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60ml | In distribution | |
| 20ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enteral | Gbuk Group Limited | 51 |
| Enteral Syringes With Enteral Specific Connectors | Ningbo Tianyi Medical Appliance Co., Ltd. | 48 |
| Kbmed | KB Medical (Group) Inc. | 31 |
| ENFit Syringe | Avanos Medical, Inc. | 30 |
| Health Care Logistics, Inc® | Health Care Logistics, Inc. | 24 |
| Ameritus ENFit | Kentec Medical, LLC | 22 |
| NeoConnect Pharmacy Syringe | Neomed Co., Ltd. | 21 |
| Monoject | Cardinal Health 200, LLC | 19 |
| NeoConnect Oral / Enteral Syringe | Neomed Co., Ltd. | 16 |
| Medline | Medline Industries, Inc. | 16 |
| Monoject | Cardinal Health | 14 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 13 |
Showing 12 of 70. All products under Enteral Syringes With Enteral Specific Connectors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203613 | 2021-08-27 |
| K203410 | 2021-06-28 |
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.