AccessGUDID - DEVICE: Inspire (00855728005192)

GUDID

Device Identifier (DI) Information

Brand Name: Inspire
Version or Model: 900-002-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4323
Company Name: Inspire Medical Systems, Inc.

Primary DI Number: 00855728005192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012419779 *Terms of Use

Device Description: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration

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:	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	001

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: dcd48898-0912-487c-99f8-e8102fa14aa6
Public Version Date: October 16, 2020
Public Version Number: 6
DI Record Publish Date: October 02, 2017