AccessGUDID - DEVICE: Inspire (00810098650038)

GUDID

Device Identifier (DI) Information

Brand Name: Inspire
Version or Model: 900-029-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2740S
Company Name: Inspire Medical Systems, Inc.

Primary DI Number: 00810098650038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012419779 *Terms of Use

Device Description: The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
63433	Implantable sleep apnoea treatment system, respiration-sensing	An 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.	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	092

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 78c2f1da-8751-4ed8-bc0e-716813949fe3
Public Version Date: May 23, 2024
Public Version Number: 1
DI Record Publish Date: May 15, 2024