Kangaroo
Kangaroo Gravity Bifurcated Extension Set
13manufacturers in China registered for this device type
6catalogue 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 |
| Record published | 2024-03-25 |
| Record revised | 2024-12-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, case of 30, case of 20 |
| Sizes | Total volume 60 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8884700108E | Total Volume 60 ml | In distribution |
| 84065E | In distribution | |
| 60VENY | In distribution | |
| 4VENS | In distribution | |
| 60VENS | In distribution | |
| 8884700116E | 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
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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.