AMT Mini ONE® Extension Set
AMT Mini ONE Extension Set connects a compatible enteral feeding device to a feeding bag or syringe for feeds or medication. It includes a Mini ONE connector, flexible tubing, pinch clamp…
AMT Mini ONE Extension Set connects a compatible enteral feeding device to a feeding bag or syringe for feeds or medication. It includes a Mini ONE connector, flexible tubing, pinch clamp and ENFit enteral connections.
Straight connectors support bolus or gravity feeding, while right-angle connectors direct tubing alongside the patient during longer administration. Tubing comes in different diameters, straight or coiled forms, and lengths from 2 to 24 inches.
Listed Item
12″ Mini ONE® Right Angle feeding set with ENFit ® [ENFit/Medication Port with Cap] (Pouched)
Port Options
Single ENFit ports provide one connection, while Y-port versions permit feeding and medication through separate capped connections. The sets are nonsterile for one patient and use materials free from DEHP and latex. Compatible interfaces include specified Mini ONE, G-Jet and Mic-Key devices.
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 | Applied Medical Technology, 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 | Manufacturer, Exporter |
| 510(k) | K142989 |
| Record published | 2016-09-09 |
| Record revised | 2024-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, box (8-1255-isosaf) of 10, box (8-2421-isosaf) of 10, box (8-1224-isosaf) of 10, box (8-1221-isosaf) of 10, box (8-1212-isosaf) of 10 |
| Sizes | Length 2 to 24 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| E8-2421-ISOSAF | Length 24 in | In distribution | |
| E8-1224-ISOSAF | Length 12 in | In distribution | |
| E8-2455-ISOSAF-NP | Length 24 in | In distribution | |
| E8-1221-ISOSAF | Length 12 in | In distribution | |
| E8-2455 | Length 24 in | In distribution | |
| E8-1212-ISOSAF | Length 12 in | In distribution | |
| E8-0212-ISOSAF | Length 2 in | In distribution | |
| 8-1255 | Length 12 in | 10 | In distribution |
| E8-1211-ISOSAF-NP | Length 12 in | In distribution | |
| E8-1223D-ISOSAF | Length 12 in | In distribution | |
| E8-0211-ISOSAF | Length 2 in | In distribution | |
| 8-1211-ISOSAF | Length 12 in | 10 | In distribution |
| 8-2455 | Length 24 in | 10 | In distribution |
| E8-1255G | Length 12 in | In distribution | |
| E8-1255-ISOSAF-NP | Length 12 in | In distribution | |
| E8-1255-ISOSAF | Length 12 in | 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 |
| 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 |
| Cardinal Health | Cardinal Health 200, LLC | 11 |
Showing 12 of 116. All products under Gastrointestinal Tubes With Enteral Specific Connectors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142989 | 2015-01-29 |
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 |
|---|---|---|---|---|---|---|
| Applied Medical Technology, Inc. | 510(k) number | 2024-11-26 | Class II | Under Investigation by firm | The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors. | 100 |
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.