Inspire

Basic Information

• Brand Name: Inspire
• Primary DI: 00855728005598
• Version / Model: 900-008-003
• Catalog Number: 2500
• Company Name: Inspire Medical Systems, Inc.
• Labeler DUNS: 012419779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-13
• Public Version: 3
• Public Version Date: 2020-10-16
• Public Version Status: Update
• Public Device Record Key: 20dd1650-8170-4760-9da4-7a94465a195f

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
34210	Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system	An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855728005598	GS1

Premarket Submissions

Submission Number	Supplement Number
P130008	009