Inspire

Primary DI
10810098650301
Brand
Inspire
Company
Inspire Medical Systems, Inc.
Model
900-014-005
Catalog number
4340
Device description
The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Published
2025-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
P130008118

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130008118INSPIRE II UPPER AIRWAY STIMULATORInspire Medical Systems2014-04-30MNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810098650301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081009865030110810098650301

GMDN Terms#

Term, Definition table
TermDefinition
Implantable sleep apnoea treatment system, respiration-sensingAn assembly of implantable devices intended for home management of obstructive sleep apnoea (OSA) by improving airway patency through stimulation of the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)], synchronous with respiration during sleep, to elicit a neuromuscular response at the base of the tongue. It consists primarily of three connected implanted components: a respiratory movement sensor, a pulse generator, and a lead to provide respiration-dependent (and alternatively, fixed-rate) electrical stimulation to the hypoglossal nerve; a patient-operated remote controller/charger and software for device configuration by a healthcare professional are typically included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012419779
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration 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
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
00810098650014Inspire900-017-005125802023-01-13
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
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
00810098650014InspireInspire Medical Systems, Inc.MNQ2023-01-13
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