Zvu® ZVU-3

GUDID 00816734023426

Manometric gastrointestinal motility analysis system

Primary Device ID	00816734023426
NIH Device Record Key	f74cc71f-d323-4277-b564-95bd26039e65
Commercial Distribution Status	In Commercial Distribution
Brand Name	Zvu®
Version Model Number	ZVU-3 Revision 3.4.0
Catalog Number	ZVU-3
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	true
Serial Number	false
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	00816734023426 [Primary]

FFX	System, Gastrointestinal Motility (Electrical)

Steralize Prior To Use	false
Device Is Sterile	false

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00816734022917	Zvu® HRiM Probe Kit
00816734022863	Zvu® Anorectal Manometry Procedure Kit
00816734022856	Zvu® Anorectal Balloons
00816734022740	HRAM Protocol for BioView
00816734022733	Zvu® HRAM Probe
00816734022689	Zvu® HRiM Probe
00816734022894	Replacement Cable for Zvu® HRiM and HRaM Probes
00816734023426	Zvu® Functional GI Software Revision 3.4.0