Monoject
Enteral Syringe 1 mL Low Dose Tip (LDT) For use with ENFit Connection System
13manufacturers in China registered for this device type
19catalogue numbers in this listing
4recalls on this 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | PNR |
| Device type | Enteral Syringes With Enteral Specific Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K190502 |
| Record published | 2023-06-13 |
| Record revised | 2024-05-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 4, box of 100, box of 40, box of 60, box of 30, box of 80 |
| Sizes | Total volume 1 to 60 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 706ABE | 1,200 | In distribution | |
| 735ABE | 300 | In distribution | |
| 760ABE | 175 | In distribution | |
| 712ABE | 1,000 | In distribution | |
| 435SE | Total Volume 35 ml | In distribution | |
| 701ASE | In distribution | ||
| 712ASE | In distribution | ||
| 400BE | 250 | In distribution | |
| 405ABE | 3,500 | In distribution | |
| 401SE | Total Volume 1 ml | In distribution | |
| 701ABE | 3,200 | In distribution | |
| 406SE | Total Volume 6 ml | In distribution | |
| 405E | 3,500 | In distribution | |
| 706ASE | In distribution | ||
| 760ASE | In distribution | ||
| 460SE | Total Volume 60 ml | In distribution | |
| 703ASE | In distribution | ||
| 703ABE | 2,000 | In distribution | |
| 735ASE | 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 |
| 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 |
| Avanos | Avanos Medical, Inc. | 12 |
Showing 12 of 70. All products under Enteral Syringes With Enteral Specific Connectors
Recalls Naming This Product
4 recalls name this product by its own identifiers, 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 |
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.