Entuit Thrive
Entuit Thrive is a balloon-retained gastrostomy feeding tube for gastric access through an established stoma. It supports enteral feeding, medication delivery and decompression in adult and…
Entuit Thrive is a balloon-retained gastrostomy feeding tube for gastric access through an established stoma. It supports enteral feeding, medication delivery and decompression in adult and pediatric patients.
The tube is primarily silicone, with a dual-lumen shaft, a molded funnel and a separate external retention bolster. A bonded silicone balloon retains the gastric end while the bolster secures the skin side. A barium-filled tip provides radiopacity.
Listed Item
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 18 FR Ref. Number: SBRD-18
Ports and Size Options
The funnel has separate feeding, medication and balloon-inflation ports. The family spans 12 to 24 French; the filed 18 French tube is one size option. The inflation valve combines a thermoplastic housing with a silicone valve, and the device is packaged without accessory devices.
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 | Xeridiem Medical Devices, United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Reprocessor, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130611 |
| Record published | 2015-06-22 |
| Record revised | 2020-04-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 18 FR | In distribution | |
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 14 FR | In distribution | |
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 22 FR | In distribution | |
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 20 FR | In distribution | |
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 24 FR | In distribution | |
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 12 FR | In distribution | |
| EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube – 16 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 |
|---|---|
| K130674 | 2014-01-13 |
| K130611 | 2013-12-19 |
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.