AccessGUDID - DEVICE: Inspire (10855728005465)

GUDID

Device Identifier (DI) Information

Brand Name: Inspire
Version or Model: 900-007-003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3028
Company Name: Inspire Medical Systems, Inc.

Primary DI Number: 10855728005465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012419779 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130008	021

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b72a43a5-2b31-49bc-88a2-fb71f4cf0f2e
Public Version Date: October 16, 2020
Public Version Number: 5
DI Record Publish Date: January 25, 2018