Infinity 100 Ml Feeding Bag Set With Enfit Connector
Catalogue number INF0100-E, listed by Zevex, Inc., United States, under Gastrointestinal Tubes With Enteral Specific Connectors. 17 manufacturers in China are registered for this product 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 | Zevex, Inc., 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, Specification developer, Manufacturer, Exporter |
| Record published | 2021-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INF0100-E | In distribution |
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 |
|---|---|
| K142539 | 2015-01-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-11-20 | Class II | Unknown/Undetermined by firm | Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. | 12,014,130 sets | 2016-08-22 |
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.