AccessGUDID - DEVICE: IOPI® (10810091040239)

GUDID

Device Identifier (DI) Information

Brand Name: IOPI®
Version or Model: Model 3.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8-3101
Company Name: Iopi Medical LLC

Primary DI Number: 10810091040239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828391396 *Terms of Use

Device Description: The IOPI® Pro (Model 3.1) is used by healthcare professionals to 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. The IOPI® Pro is intended for clinical use by healthcare professionals.

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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 65 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e25e926-2aa9-4efd-9379-f84e755ae424
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 21, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10810091040253	1	10810091040239	In Commercial Distribution	1-3100-SD_EN
10810091040321	1	10810091040239	In Commercial Distribution	1-3100-SD_ES
10810091040260	1	10810091040239	In Commercial Distribution	1-3100-DL_EN
10810091040420	1	10810091040239	In Commercial Distribution	1-3100-DL_ES