Cardinal Health
The 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…
The 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 in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
13manufacturers in China registered for this device type
12catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Jiangsu Caina Medical 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, Exporter |
| 510(k) | K190502 |
| Record published | 2023-07-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4, pack of 100, pack of 80, pack of 6, pack of 30, pack of 40 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6ml | 1,200 | In distribution | |
| 3ml | 2,000 | In distribution | |
| 3ml | In distribution | ||
| 12ml | In distribution | ||
| 1mL | 3,200 | In distribution | |
| 12ml | 1,000 | In distribution | |
| 60ml | In distribution | ||
| 35mL | 300 | In distribution | |
| 60mL | 175 | In distribution | |
| 35ml | In distribution | ||
| 6ml | In distribution | ||
| 1ml | 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 |
|---|---|
| K211593 | 2021-09-30 |
| K190502 | 2019-08-06 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | 510(k) number | 2023-12-28 | Class I | Process change control | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used | 20186 units |
| Cardinal Health 200, LLC | 510(k) number | 2023-12-28 | Class I | Process change control | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used | 60760 units |
| Cardinal Health 200, LLC | 510(k) number | 2023-12-28 | Class I | Process change control | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used | 223056 units |
| Cardinal Health 200, LLC | 510(k) number | 2023-12-28 | Class I | Process change control | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used | 397676 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile | |
| Cardinal Health 200, LLC | UDI-DI | 2023-12-28 | Class I | Process change control | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile |
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.