AccessGUDID - DEVICE: IOPI® (10810091040284)

GUDID

Device Identifier (DI) Information

Brand Name: IOPI®
Version or Model: Report Generator v 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-8101
Company Name: Iopi Medical LLC

Primary DI Number: 10810091040284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828391396 *Terms of Use

Device Description: IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
63454	Dynamometer force gauge	An electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKE	Transducer, Miniature Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: eb6f1464-b736-4e24-bca5-e79f60b30e56
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 21, 2025