Device Description; Intended Use/Indications For Use - COOK Medical Enluit Thrive Instrucciones De Uso

ENGLISH
ENTUIT THRIVE
™
BALLOON RETENTION GASTROSTOMY FEEDING TUBE
Instructions For Use:
CAUTION: U.S. federal law restricts this device to sale by or on the order of a
physician (or properly licensed practitioner).
Contents of package:
1 - Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube

DEVICE DESCRIPTION

The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is a sterile device
consisting of a silicone balloon, bi-lumen shaft, three-port funnel and bolster that
allows for proper retention during enteral feeding, medication administration and
decompression. The device contains one valve that allows for inflation and deflation of
the silicone balloon.

INTENDED USE/INDICATIONS FOR USE

The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is intended to
provide gastric access for enteral feeding, medication administration and
decompression through an established gastrointestinal stoma tract.
The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is indicated for use
in percutaneous placement of an enteral feeding tube in adult and pediatric patients
that require enteral feeding, medication administration or decompression through an
established gastrointestinal stoma tract.
CONTRAINDICATIONS
Device placement is contraindicated for patients with evidence of granulation tissue,
infection, and/or irritation in the stoma site.
WARNING
• Inspect package integrity before use. Do not use device if package is damaged or
if the sterile barrier has been compromised. Do not use if labeling is incomplete or
illegible.
• Do not resterilize or reprocess this medical device as this may have an adverse
effect on the known characteristics of the structural integrity, performance and
biocompatibility of the device.
• For single patient use only. Do not reuse this medical device as this may increase
the risk of contamination leading to transmission of infectious diseases which has
the potential of resulting in patient injury, illness or death.
• FOR ENTERAL USE ONLY.The device is intended to connect to enteral
giving sets for enteral feeding, and syringes for feeding, medication and
inflation of balloon.
• This device has KNOWN misconnections with connectors found in the
following medical devices/healthcare applications:
- Intravascular devices;
- Hypodermic applications;
- Breathing systems and driving gas devices;
- Urethral/urinary devices;
- Limb cuff inflation devices;
- Neuraxial devices
• Do NOT use this product in the vasculature.
• Once used, dispose of packaging and package contents in accordance with
healthcare institution guidelines and/or local government policy.
PRECAUTIONS
• This device should only be used for its intended purpose by or under the
supervision of trained healthcare professionals with a comprehensive
understanding in clinical principles, procedures and risks associated with
percutaneous placement of enteral feeding devices. It is recommended to adhere
to the instructions for use provided with this device, the enteral feeding instructions
for the healthcare facility and instructions recommended by physicians.
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