HeartCentrix

GUDID 00812345029994

Cardiology Data Management System

MORTARA INSTRUMENT, INC.

Patient health record information system application software

• Primary Device ID: 00812345029994
• NIH Device Record Key: 7bbdbfda-9def-41a4-b9bf-1ff4198b6d99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartCentrix
• Version Model Number: 11098-002-50
• Company DUNS: 062046149
• Company Name: MORTARA INSTRUMENT, 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: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345029994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032038

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-24

On-Brand Devices [HeartCentrix]

• 00812345029994: Cardiology Data Management System
• 00812345029802: Cardiology Data Management System