PriZm PRIZMCART-II

GUDID 00816734023075

PriZm Base Cart System

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 00816734023075
• NIH Device Record Key: bee67342-7eb9-4968-8dbe-ce98b55bc9ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PriZm
• Version Model Number: PRIZMCART-II
• Catalog Number: PRIZMCART-II
• 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
• 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	00816734023075 [Primary]

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [PriZm]

• 00816734022887: PriZm Base System
• 00816734022870: PriZm Base Cart System
• 00816734022757: PriZm® Central Unit
• 00816734022993: PriZm® Central Unit
• 00816734022610: PriZm® Upgrade Kit
• 00816734023099: PriZm Base System
• 00816734023082: PriZm Upgrade Kit
• 00816734023075: PriZm Base Cart System
• 00816734023068: PriZm® Central Unit