MiVu MI-BAL-01

GUDID 00816734022481

MiVu Balloon

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 00816734022481
• NIH Device Record Key: 527ad0b9-38e9-4adc-ae02-8c7a8d3b7d1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiVu
• Version Model Number: MI-BAL-01
• Catalog Number: MI-BAL-01
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.com
• Phone: 800-558-6408
• Email: sales@diverstakhc.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 Dimensions

• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter
• Balloon Diameter: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734022481 [Primary]

FDA Product Code

• QIS: Esophageal, Mucosal, Electrical Characterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-07-08
• Device Publish Date: 2020-11-06

On-Brand Devices [MiVu]

• 00816734022481: MiVu Balloon
• 00816734022948: PriZm Upgrade Kit for MiVu Mucosal Integrity
• 00816734022931: MiVu Mucosal Integrity Starter Kit
• 00816734022900: MiVu Mucosal Integrity Inflation Syringe and Extension Tubing
• 00816734022719: MiVu Mucosal Integrity Regulator
• 00816734021842: MiVu Mucosal Integrity Cable
• 00816734023167: MiVu Endo Cap Cable
• 00816734023143: MiVu Esophageal Endo Cap