Inspire 3028

GUDID 10855728005915

The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

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 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 Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Primary Device ID10855728005915
NIH Device Record Keye5b11a26-6ddd-40a4-95d0-4b2ba6e15eb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameInspire
Version Model Number900-007-014
Catalog Number3028
Company DUNS012419779
Company NameInspire Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110855728005915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNQStimulator, Hypoglossal Nerve, Implanted, Apnea

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-21
Device Publish Date2021-01-13

On-Brand Devices [Inspire]

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

Trademark Results [Inspire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSPIRE
INSPIRE
98407977 not registered Live/Pending
Sahara Group LLC
2024-02-16
INSPIRE
INSPIRE
98373585 not registered Live/Pending
STX SOFTWARE, LLC
2024-01-24
INSPIRE
INSPIRE
98223123 not registered Live/Pending
1426391 B.C. LTD.
2023-10-13
INSPIRE
INSPIRE
98074438 not registered Live/Pending
Megan Mae Beauty Products LLC
2023-07-07
INSPIRE
INSPIRE
98071172 not registered Live/Pending
Authentic Walk Creative Inc.
2023-07-05
INSPIRE
INSPIRE
98003183 not registered Live/Pending
TDC Development, Inc.
2023-05-18
INSPIRE
INSPIRE
97739001 not registered Live/Pending
Inspire To Better LLC
2023-01-02
INSPIRE
INSPIRE
97587138 not registered Live/Pending
Inspire Event Technologies, LLC
2022-09-12
INSPIRE
INSPIRE
97587127 not registered Live/Pending
Inspire Event Technologies, LLC
2022-09-12
INSPIRE
INSPIRE
97475178 not registered Live/Pending
JJ Acquisition, LLC
2022-06-24
INSPIRE
INSPIRE
97327228 not registered Live/Pending
Inspire Brands, Inc.
2022-03-23
INSPIRE
INSPIRE
97194489 not registered Live/Pending
O'Driscoll, Peter
2021-12-29

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