Zvu® HRAM-200

GUDID 00816734022733

Manometric gastrointestinal motility analysis system

Primary Device ID	00816734022733
NIH Device Record Key	0fac9dcd-fa17-4f65-b2f9-43e174f8c225
Commercial Distribution Status	In Commercial Distribution
Brand Name	Zvu®
Version Model Number	HRAM-200
Catalog Number	HRAM-200
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	00816734022733 [Primary]

FFX	System, Gastrointestinal Motility (Electrical)

Steralize Prior To Use	true
Device Is Sterile	false

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

[00816734022733]

High-level Disinfectant

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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