ENFit Feeding Port Transition Connector
Catalogue number M00509240, listed by Xeridiem Medical Devices, United States, under Gastrointestinal Tubes With Enteral Specific Connectors. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (4), Guangdong (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Jiangsu Kangjin Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Ucomfor Scientific Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
Showing 12 of 17. All 17 manufacturers in China registered for Gastrointestinal Tubes With Enteral Specific Connectors
Record
| Listed by | Xeridiem Medical Devices, United States |
|---|---|
| FDA product code | PIF |
| Device type | Gastrointestinal Tubes With Enteral Specific Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Reprocessor, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K142297 |
| Record published | 2016-08-01 |
| Record revised | 2026-04-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case box of 10 |
| Distribution end date | 2025-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00509240 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Micro G-Jet® | Applied Medical Technology, Inc. | 52 |
| Nutricare | Gbuk Group Limited | 44 |
| Enteral | Gbuk Group Limited | 42 |
| Traditional G-Jet® | Applied Medical Technology, Inc. | 37 |
| Medline | Medline Industries, Inc. | 22 |
| Kangaroo | Cardinal Health 200, LLC | 17 |
| Aquarius | Degania Silicone, Ltd. | 16 |
| AMT Mini ONE® Extension Set | Applied Medical Technology, Inc. | 16 |
| EndoVive™ One Step Button™ | Boston Scientific Corporation | 14 |
| Vesco Medical Pediatric Nasogastric Feeding Tubes | Cair LGL | 13 |
| Kangaroo | Cardinal Health | 13 |
| Vesco Medical Nasogastric Feeding Tubes | Cair LGL | 12 |
Showing 12 of 116. All products under Gastrointestinal Tubes With Enteral Specific Connectors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171347 | 2017-06-06 |
Recalls Naming This Product
104 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 | Closed |
|---|---|---|---|---|---|---|---|
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 36 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 260 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 199 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 165 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 243 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 326 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 77 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 33 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 235 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 331 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 191 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 78 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 34 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 32 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 38 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 323 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 189 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 77 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 35 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 205 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 186 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 80 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 36 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 34 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 36 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 154 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 77 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| Xeridiem Medical Devices | 510(k) number | 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 35 | 2016-10-25 |
Showing 40 of 104.
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.