Zvu® HRAM-200

GUDID 00816734022733

Zvu® HRAM Probe

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system 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

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

Device Dimensions

• Catheter Gauge: 17 French
• Catheter Gauge: 17 French
• Catheter Gauge: 17 French
• Catheter Gauge: 17 French
• Catheter Gauge: 17 French
• Catheter Gauge: 17 French
• Catheter Gauge: 17 French
• Catheter Gauge: 17 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734022733 [Primary]

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

• 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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Zvu®]

• 00816734022924: Zvu® HRAM Starter Kit
• 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