Zvu ZVU-2016

GUDID 00816734022429

Zvu® Advanced GI Diagnostic Software

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 00816734022429
• NIH Device Record Key: 56aabffd-c017-4832-a380-9479bca1bdf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zvu
• Version Model Number: ZVU-2016
• Catalog Number: ZVU-2016
• 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

Customer Support Contacts

• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734022429 [Primary]
HIBCC	B019ZVU20160 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012232

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2023-06-14
• Device Publish Date: 2016-09-24

Devices Manufactured by DIVERSATEK HEALTHCARE, INC.

• 00816734022825 - Zvu®: 2025-11-24 ZVU® Functional GI Software
• M78312011161 - Diversatek Healthcare: 2025-11-24 Basic Endoscopy Procedure Kit
• 00816734023433 - Diversatek Healthcare: 2025-05-26 Manometry Starter Kit
• 00816734023440 - Diversatek Healthcare: 2025-05-26 HRiM2 High Resolution Impedance Manometry Probe Kit
• 00816734023457 - Diversatek Healthcare: 2025-05-26 HRiM SD High Resolution Impedance Manometry Probe Kit
• 00816734023464 - Diversatek Healthcare: 2025-05-26 High Resolution Anorectal Manometry Probe Kit
• 00816734023471 - Diversatek Healthcare: 2025-05-26 Anal Sphincter Electromyography Kit
• 00816734023488 - Diversatek Healthcare: 2025-05-26 Desktop PC with Zvu Software