Inspire 2580

GUDID 00855728005925

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

Inspire Medical Systems, Inc.

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

• Primary Device ID: 00855728005925
• NIH Device Record Key: f6934f62-ada8-4a4c-95d6-4750540af620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspire
• Version Model Number: 900-017-001
• Catalog Number: 2580
• Company DUNS: 012419779
• Company Name: Inspire Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00855728005925 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-17
• Device Publish Date: 2022-05-09

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