Inspire

Primary DI
00810098650014
Brand
Inspire
Company
Inspire Medical Systems, Inc.
Model
900-017-0051
Catalog number
2580
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.
Published
2023-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MNQStimulator, Hypoglossal Nerve, Implanted, Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNQStimulator, Hypoglossal Nerve, Implanted, ApneaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130008069

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130008069INSPIRE II UPPER AIRWAY STIMULATORInspire Medical Systems2014-04-30MNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810098650014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810098650014008100986500148100986500140810098650014

GMDN Terms#

Term, Definition table
TermDefinition
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation systemAn 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.

Regulatory Flags#

DUNS number
012419779
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810098650066Inspire900-023-00150302025-10-29
10855728005793Inspire900-013-00140632025-07-29
10810098650295Inspire900-013-00340632025-02-24
00855728005796Inspire900-013-00140632022-08-16
10810098650301Inspire900-014-00543402025-02-24
00810098650311Inspire900-026-0012740S&C2025-01-21
10855728005960Inspire900-015-00131502024-12-06
00810098650175Inspire900-017-00525802024-10-10
00810098650199Inspire900-017-05325802024-10-10
00855728005994Inspire900-018-0012740C2024-09-11
10810098650264Inspire900-007-01930282024-07-08
00810098650038Inspire900-029-0012740S2024-05-15
00810098650212Inspire900-004-11727402024-01-03
00810098650151Inspire900-004-11627402023-04-26
10810098650141Inspire900-007-01730282023-04-06
00810098650083Inspire900-017-00325802022-09-29
00855728005949Inspire900-014-00343402022-08-16
00855728005925Inspire900-017-00125802022-05-09
00810098650007Inspire900-004-11527402022-01-26
00855728005741Inspire900-004-11127402021-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404031018723Genio System 2.1NyxoahMNQ2025-08-27
05404031000001Genio System 2.1NyxoahMNQ2025-08-26
05404031000018Genio System 2.1NyxoahMNQ2025-08-26
05404031000025Genio System 2.1NyxoahMNQ2025-08-26
05404031000049Genio System 2.1NyxoahMNQ2025-08-26
05404031018693Genio System 2.1NyxoahMNQ2025-08-26
05404031024755Genio System 2.1NyxoahMNQ2025-08-26
05404031024786Genio System 2.1NyxoahMNQ2025-08-26
05404031024823Genio System 2.1NyxoahMNQ2025-08-26
05404031024847Genio System 2.1NyxoahMNQ2025-08-26
05404031025301Genio System 2.1NyxoahMNQ2025-08-26
10855728005793InspireInspire Medical Systems, Inc.MNQ2025-07-29
10810098650295InspireInspire Medical Systems, Inc.MNQ2025-02-24
10810098650301InspireInspire Medical Systems, Inc.MNQ2025-02-24
00810098650311InspireInspire Medical Systems, Inc.MNQ2025-01-21
10855728005960InspireInspire Medical Systems, Inc.MNQ2024-12-06
00810098650175InspireInspire Medical Systems, Inc.MNQ2024-10-10
00810098650199InspireInspire Medical Systems, Inc.MNQ2024-10-10
00855728005994InspireInspire Medical Systems, Inc.MNQ2024-09-11
10810098650264InspireInspire Medical Systems, Inc.MNQ2024-07-08
00810098650038InspireInspire Medical Systems, Inc.MNQ2024-05-15
00810098650212InspireInspire Medical Systems, Inc.MNQ2024-01-03
00810098650151InspireInspire Medical Systems, Inc.MNQ2023-04-26
10810098650141InspireInspire Medical Systems, Inc.MNQ2023-04-06
00810098650083InspireInspire Medical Systems, Inc.MNQ2022-09-29
00855728005796InspireInspire Medical Systems, Inc.MNQ2022-08-16
00855728005949InspireInspire Medical Systems, Inc.MNQ2022-08-16
00855728005925InspireInspire Medical Systems, Inc.MNQ2022-05-09
00810098650007InspireInspire Medical Systems, Inc.MNQ2022-01-26
00855728005741InspireInspire Medical Systems, Inc.MNQ2021-03-19