Inspire 4063

GUDID 10855728005809

The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.

Inspire Medical Systems, Inc.

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

• Primary Device ID: 10855728005809
• NIH Device Record Key: 1bdc56fb-4706-4802-8571-45b6b1210b6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspire
• Version Model Number: 900-001-011
• Catalog Number: 4063
• Company DUNS: 012419779
• Company Name: Inspire Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855728005809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130008

FDA Product Code

• MNQ: Stimulator, Hypoglossal Nerve, Implanted, Apnea

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-29
• Device Publish Date: 2021-03-19

On-Brand Devices [Inspire]

• 10855728005526: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005496: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005458: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005762: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 10855728005915: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 10855728005892: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005809: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
• 00855728005826: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 00855728005741: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 00810098650007: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 00855728005925: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 00855728005949: The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. Th
• 00855728005796: The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossa
• 00810098650083: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 10810098650141: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 00810098650151: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 00810098650212: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 00810098650038: The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and
• 10810098650264: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 00855728005994: The Model 2740C Programmer Cable is responsible for transferring device data from the generator
• 00810098650199: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 00810098650175: The sleep remote is an external device that is about the size of a cell phone and is used by the