Micro G-Jet®
14FR x 1.5 cm x 30 cm - AMT micro G-Jet® Low Profile Transgastric-Jejunal Feeding Device (ENFit®), MDR
17manufacturers in China registered for this device type
52catalogue numbers in this listing
1510(k) clearance
1recall
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) | K183508 |
| Record published | 2024-10-11 |
| Record revised | 2022-04-08 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Catheter gauge 8 to 14 Fr; length 0.8 to 30 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MGJ-1420-22 | Catheter Gauge 8 Fr | In distribution |
| MGJ-1412-15 | Length 15 cm | In distribution |
| MGJ-1408-22-I | Length 0.8 cm | In distribution |
| MGJ-1415-30-I | Length 30 cm | In distribution |
| MGJ-1415-10 | Length 10 cm | In distribution |
| MGJ-1420-30 | Length 2.0 cm | In distribution |
| MGJ-1408-22-I | Length 0.8 cm | In distribution |
| MGJ-1420-30-I | Length 2.0 cm | In distribution |
| MGJ-1408-10 | Length 0.8 cm | In distribution |
| MGJ-1420-30 | Length 2.0 cm | In distribution |
| MGJ-1410-15-I | Catheter Gauge 14 Fr | In distribution |
| MGJ-1420-30-I | Length 2.0 cm | In distribution |
| MGJ-1412-22-I | Catheter Gauge 14 Fr | In distribution |
| MGJ-1423-30-I | Length 2.3 cm | In distribution |
| MGJ-1415-10 | Length 10 cm | In distribution |
| MGJ-1423-22-I | Length 2.3 cm | In distribution |
| MGJ-1408-15-I | Length 0.8 cm | In distribution |
| MGJ-1415-15-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1423-22 | Length 2.3 cm | In distribution |
| MGJ-1408-22 | Length 0.8 cm | In distribution |
| MGJ-1423-30 | Length 2.3 cm | In distribution |
| MGJ-1417-10-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1415-30-I | Length 30 cm | In distribution |
| MGJ-1410-22 | Length 1.0 cm | In distribution |
| MGJ-1415-30 | Length 30 cm | In distribution |
| MGJ-1410-22 | Length 1.0 cm | In distribution |
| MGJ-1420-22-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1417-22-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1423-30 | Length 2.3 cm | In distribution |
| MGJ-1423-22 | Length 2.3 cm | In distribution |
| MGJ-1412-10-I | Catheter Gauge 14 Fr | In distribution |
| MGJ-1415-22 | Length 22 cm | In distribution |
| MGJ-1415-15-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1417-15 | Length 15 cm | In distribution |
| MGJ-1417-15 | Length 15 cm | In distribution |
| MGJ-1412-22-I | Catheter Gauge 14 Fr | In distribution |
| MGJ-1408-10 | Length 0.8 cm | In distribution |
| MGJ-1410-10 | Catheter Gauge 8 Fr | In distribution |
| MGJ-1420-22 | Catheter Gauge 8 Fr | In distribution |
| MGJ-1412-10-I | Catheter Gauge 14 Fr | In distribution |
| MGJ-1417-10-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1415-22 | Length 22 cm | In distribution |
| MGJ-1408-22 | Length 0.8 cm | In distribution |
| MGJ-1410-10 | Catheter Gauge 8 Fr | In distribution |
| MGJ-1408-15-I | Length 0.8 cm | In distribution |
| MGJ-1423-22-I | Length 2.3 cm | In distribution |
| MGJ-1420-22-I | Catheter Gauge 8 Fr | In distribution |
| MGJ-1410-15-I | Catheter Gauge 14 Fr | In distribution |
| MGJ-1415-30 | Length 30 cm | In distribution |
| MGJ-1412-15 | Length 15 cm | In distribution |
| MGJ-1423-30-I | Length 2.3 cm | In distribution |
| MGJ-1417-22-I | Catheter Gauge 8 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
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 |
|---|---|---|---|---|
| 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.