AccessGUDID - DEVICE: Inspire (00810098650311)

GUDID

Device Identifier (DI) Information

Brand Name: Inspire
Version or Model: 900-026-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2740S&C
Company Name: Inspire Medical Systems, Inc.

Primary DI Number: 00810098650311
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&C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.

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: cceb12ef-8e01-4b7b-be79-7840730b7fb1
Public Version Date: January 29, 2025
Public Version Number: 1
DI Record Publish Date: January 21, 2025