inSIGHT Ultima H12R-4300

GUDID 00816734021958

Manometric gastrointestinal motility analysis system

Primary Device ID	00816734021958
NIH Device Record Key	8c22a579-b5fd-4c8f-a5aa-20ad1c54e74f
Commercial Distribution Status	In Commercial Distribution
Brand Name	inSIGHT Ultima
Version Model Number	H12R-4300
Catalog Number	H12R-4300
Company DUNS	030650113
Company Name	DIVERSATEK HEALTHCARE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00816734021958 [Primary]
HIBCC	B019H12R43000 [Secondary]

FFX	System, Gastrointestinal Motility (Electrical)

Steralize Prior To Use	false
Device Is Sterile	false

00816734023112	inSIGHT Ultima Base System
00816734023105	inSIGHT Ultima Base Cart System
00816734021958	inSight Ultima® EMG Adaptor
00816734021941	InSight Ultima® Central Unit

Mark Image Registration \| Serial	Company Trademark Application Date
INSIGHT ULTIMA 86504174 4799320 Live/Registered	Sandhill Scientific, Inc. 2015-01-15