Ultima H12R-7110

GUDID 00816734023006

Ultima Cable for High Resolution Manometry Probe

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 00816734023006
• NIH Device Record Key: 30eb9a35-e67a-4e58-bb27-65251c2e7fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultima
• Version Model Number: H12R-7110
• Catalog Number: H12R-7110
• 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: false
• Manufacturing Date: true
• 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@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.com
• Phone: 800-558-6408
• Email: sales@diversatek.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	00816734023006 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [Ultima]

• 00816734023013: Ultima Cable for HRCA Manometry Probe (Lemo Connector)
• 00816734023006: Ultima Cable for High Resolution Manometry Probe