IOPI® 5-8101

GUDID 10810091040062

Dynamometer force gauge

Primary Device ID	10810091040062
NIH Device Record Key	d3e433fd-7db0-4a7d-9768-734a4c7fb130
Commercial Distribution Status	In Commercial Distribution
Brand Name	IOPI®
Version Model Number	Report Generator v 1.0
Catalog Number	5-8101
Company DUNS	828391396
Company Name	Iopi Medical LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10810091040055 [Primary]
GS1	10810091040062 [Package] Contains: 10810091040055 Package: Bag (EN) [1 Units] In Commercial Distribution
GS1	10810091040185 [Package] Contains: 10810091040055 Package: Bag (ES) [1 Units] In Commercial Distribution

IKE	Transducer, Miniature Pressure

Steralize Prior To Use	false
Device Is Sterile	false

10810091040062	IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro
10810091040024	The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and
10810091040000	The IOPI® Pro (Model 3.1) is used by medical professionals to measure, evaluate, and increase t

Mark Image Registration \| Serial	Company Trademark Application Date
IOPI 77740419 3725288 Live/Registered	IOPI Northwest Co. LLC 2009-05-19