Gabriel Feeding Tube With Balloon
Gabriel Feeding Tube with Balloon delivers enteral nutrition directly into the small bowel. It is intended for adults and elderly patients with a functioning gut who cannot consume an…
Gabriel Feeding Tube with Balloon delivers enteral nutrition directly into the small bowel. It is intended for adults and elderly patients with a functioning gut who cannot consume an adequate diet orally and need short- to moderate-term feeding support. An inflated balloon allows peristalsis to advance the tube distally.
The tube has a DEHP-free PVC patient-contacting outer layer reinforced with stainless-steel monofilament wire to resist kinking. Placement uses a stylet, which is removed afterward. Position is verified with pH paper and abdominal X-ray before the tube is secured at the nose.
Listed Item
Preassembeled with Stylet
Stylet Configurations
A magnetic stylet version uses an external steering magnet and a distal reed switch linked to an LED indicator. A separate nonmagnetic stylet version is inserted manually by the physician. Its braided stainless-steel stylet is shorter than the tube and does not contact the patient.
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | Syncro Medical Innovations, Inc., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160787 |
| Record published | 2019-01-24 |
| Record revised | 2020-02-06 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Sizes | Catheter gauge 8 to 12 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10 Fr | Catheter Gauge 10 Fr | In distribution |
| 8 Fr | Catheter Gauge 8 Fr | In distribution |
| 8 Fr | Catheter Gauge 8 Fr | In distribution |
| 10 Fr | 10 Fr (3.7mm)X 49”(100cm) | In distribution |
| 12 Fr | Catheter Gauge 12 Fr | In distribution |
| 12 Fr | Catheter Gauge 12 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160787 | 2016-08-09 |
| K110005 | 2011-08-04 |
| K072787 | 2007-10-31 |
| K021991 | 2002-07-18 |
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.