Medline
DBD-Enfit Piston Syringe,feed Tray, 30/C
17manufacturers in China registered for this device type
22catalogue numbers in this listing
3510(k) clearances naming 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | PIF |
| Device type | Gastrointestinal Tubes With Enteral Specific Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2021-10-08 |
| Record revised | 2024-04-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep away from sunlight. Keep dry. |
| Packaging | Case of 10, case of 30, case of 50 |
| Sizes | Catheter gauge 6 to 12 Fr; length 50 to 120 cm; total volume 60 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENFIT05050 | In distribution | |
| ENFIT7061 | In distribution | |
| ENFIT08120S | Catheter Gauge 8 Fr | In distribution |
| ENFIT06050 | In distribution | |
| ENFIT70642 | In distribution | |
| ENFIT12092S | Length 92 cm | In distribution |
| ENFIT08050S | Length 50 cm | In distribution |
| ENFIT08050 | In distribution | |
| ENFIT08080S | Length 80 cm | In distribution |
| ENFIT05075 | In distribution | |
| ENFIT20335 | Total Volume 60 ml | In distribution |
| ENFIT08075 | In distribution | |
| ENFIT04050 | In distribution | |
| ENFIT08092S | Length 92 cm | In distribution |
| ENFIT10075 | In distribution | |
| ENFIT9000NS | In distribution | |
| ENFIT04075 | In distribution | |
| ENFIT10092S | Catheter Gauge 10 Fr | In distribution |
| ENFIT06080S | Length 80 cm | In distribution |
| ENFIT9000S | In distribution | |
| ENFIT06050S | Catheter Gauge 6 Fr | In distribution |
| ENFIT06075 | 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 |
| 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 |
|---|---|
| K191759 | 2019-12-04 |
| K160642 | 2016-11-29 |
| K150286 | 2015-04-27 |
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.