- Physicians Office Resource

BALLOON 1830616EST EUSTACHIAN 6X16MM
NuVent - 1830616EST

Device Description

A long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PNZ

Device Name: Eustachian Tube Balloon Dilation Device

Device Class: 2

Physical State: A Eustachian tube balloon dilation device consists of a catheter with an inflatable, plastic balloon, which is located at the flexible, distal end. The catheter shaft has a dual lumen to enable inflation of the balloon and has a soft, balled tip to prevent advancement into the bony isthmus of the Eustachian tube. The catheter materials are primarily plastic and stainless steel and the balloon is also plastic. The catheter joints are bonded using adhesives.

Definition: The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

Submission Type ID: 1

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The balloon catheter is loaded through a guide catheter through the nose to the Eustachian tube. The balloon is manually advanced and inserted into the cartilaginous Eustachian tube and inflated to a desired pressure and specified duration. The balloon is then deflated and removed from the nose.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Eustachian tube

Regulation Number: 874.4180

Third Party Flag: N

Medical Specialty: EN

Device Identifiers

Device Id: 00763000416034

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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