G-tubes
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
by Xeridiem Medical Devices, Inc.
A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.
Where to buy Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
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Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| SBRD-12-ENF | Catheter Gauge 12 Fr | MR Conditional | Available |
| SBRD-14-ENF | Catheter Gauge 14 Fr | MR Conditional | Available |
| SBRD-16-ENF | Catheter Gauge 16 Fr | MR Conditional | Available |
| SBRD-18-ENF | Catheter Gauge 18 Fr | MR Conditional | Available |
| SBRD-20-ENF | Catheter Gauge 20 Fr | MR Conditional | Available |
| SBRD-22-ENF | Catheter Gauge 22 Fr | MR Conditional | Available |
| SBRD-24-ENF | Catheter Gauge 24 Fr | MR Conditional | Available |
FDA clearances
- 510(k) K171347 June 2017
- 510(k) K130611 December 2013
Procedures that use g-tubes
Frequently asked questions
What is Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection used for?
A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.
Who makes Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection?
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection is made by Xeridiem Medical Devices, Inc.. It is listed under gastrostomy and gj tubes in our device library.
What sizes does Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection come in?
Sizes listed for Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection: Catheter Gauge: 12–24 Fr. Confirm availability with the manufacturer's instructions for use.
Is Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection MRI safe?
The FDA device database lists Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection FDA cleared?
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection is covered by FDA submissions K130611, K171347.
How do I contact a Xeridiem Medical Devices, Inc. sales representative?
Xeridiem Medical Devices, Inc. has not listed representatives on LA Vascular yet. Visit the Xeridiem Medical Devices, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.