Enteral Feeding
INTOPO Convert to Oral Syringe, Bulk, Non-Sterile
60manufacturers in China registered for this device type
87catalogue numbers in this listing
2recalls on this code
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 | Medela LLC, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K894206 |
| Record published | 2016-09-22 |
| Record revised | 2024-09-30 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50, pack of 100, pack of 25 |
| Distribution end date | 2024-05-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| INT-30 | In distribution | ||
| NTL05 | In distribution | ||
| TL-INT-05 | In distribution | ||
| NTL10 | In distribution | ||
| LID60 | In distribution | ||
| PLG-10 | In distribution | ||
| NTL60 | In distribution | ||
| TL-INT-30 | In distribution | ||
| TL-INT-10 | In distribution | ||
| ENFFEMALELD | In distribution | ||
| NTL-60 | In distribution | ||
| LID10 | In distribution | ||
| INT-20 | In distribution | ||
| ENFMALELD | In distribution | ||
| INT-10 | In distribution | ||
| TL-INT-03 | In distribution | ||
| PLG60 | In distribution | ||
| LID-60 | In distribution | ||
| TLCAP | 10 | In distribution | |
| PLG-30 | In distribution | ||
| LID-10 | In distribution | ||
| PLG-60 | In distribution | ||
| PLG10 | In distribution | ||
| INT-01 | In distribution | ||
| ENF60 | In distribution | ||
| ENF30 | In distribution | ||
| LID30 | In distribution | ||
| ENFDUALCAPNSLD | 500 | In distribution | |
| ENFDUALCAPLD | In distribution | ||
| PLG30 | In distribution | ||
| INT-05 | In distribution | ||
| NTL30 | In distribution | ||
| TL-INT-60 | In distribution | ||
| LID-30 | In distribution | ||
| INT-60 | In distribution | ||
| ENFMEDCAPLD | 10 | In distribution | |
| NTL-30 | In distribution | ||
| ENFDOSECAPLD | In distribution | ||
| ENFCAPLD | In distribution | ||
| INT01 | In distribution | ||
| TL-INT-20 | In distribution | ||
| INT03 | In distribution | ||
| NTL-05 | In distribution | ||
| ENF10 | In distribution | ||
| NGF-60ST | In distribution | ||
| ENF05 | In distribution | ||
| NTL-10 | In distribution | ||
| INT-03 | In distribution | ||
| NGF30ST | Withdrawn | ||
| NGF60ST | Withdrawn | ||
| 7771 | 10 | Withdrawn | |
| ENFFEMALE | Withdrawn | ||
| ENFDUALCAP | Withdrawn | ||
| TL-CAP | 10 | Withdrawn | |
| TLINT60 | Withdrawn | ||
| INT30 | Withdrawn | ||
| ENFCAP | Withdrawn | ||
| ENFMEDCAP | 10 | Withdrawn | |
| NGF-30ST | Withdrawn | ||
| INT60 | Withdrawn | ||
| ENFDUALCAPCLD | Withdrawn | ||
| NGF30 | Withdrawn | ||
| INT05 | Withdrawn | ||
| NGF-30 | Withdrawn | ||
| INTCAP | Withdrawn | ||
| 7772 | 500 | Withdrawn | |
| INT-CAP | Withdrawn | ||
| INT10 | Withdrawn | ||
| ENFGF60 | Withdrawn | ||
| TLINT10 | Withdrawn | ||
| ENFMALE | Withdrawn | ||
| NGF60 | Withdrawn | ||
| ENFMEDCAPNSLD | 500 | Withdrawn | |
| ENFDUALCAPNS | 500 | Withdrawn | |
| ENFGF30 | Withdrawn | ||
| NGF10 | Withdrawn | ||
| INT20 | Withdrawn | ||
| NGF-10 | Withdrawn | ||
| 7773 | Withdrawn | ||
| NGF-60 | Withdrawn | ||
| TLINT03 | Withdrawn | ||
| ENFGF10 | Withdrawn | ||
| ENFMEDCAPNS | 500 | Withdrawn | |
| TLINT30 | Withdrawn | ||
| TLINT05 | Withdrawn | ||
| ENFDUALCAPCNSLD | 500 | Withdrawn | |
| TLINT20 | 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 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| 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 | Closed |
|---|---|---|---|---|---|---|---|
| Medela LLC | 510(k) number | 2015-02-13 | Class II | Packaging | The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging. | 1,959,187 | 2015-11-09 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-12-05 | Class III | Equipment maintenance | The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. | 665,600 lids (6,656 cases) | 2020-08-25 |
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.