Q-Stress

GUDID 00817655021881

Cardiac Stress Testing System

MORTARA INSTRUMENT, INC.

Cardiac stress exercise monitoring system

• Primary Device ID: 00817655021881
• NIH Device Record Key: 5f4cf3b8-71fe-40b4-b17d-a0367a3729d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Stress
• Version Model Number: QS-6FC-AXDXA
• 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: 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: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817655021881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001492

FDA Product Code

• DPS: Electrocardiograph

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: 2017-08-18

On-Brand Devices [Q-Stress]

• 00812345027723: Cardiac Stress Testing System
• 00812345027716: Cardiac Stress Testing System
• 00812345027709: Cardiac Stress Testing System
• 00812345027693: Cardiac Stress Testing System
• 00812345027686: Cardiac Stress Testing System
• 00812345027679: Cardiac Stress Testing System
• 00812345027662: Cardiac Stress Testing System
• 00812345027655: Cardiac Stress Testing System
• 00812345027648: Cardiac Stress Testing System
• 00812345027631: Cardiac Stress Testing System
• 00812345027624: Cardiac Stress Testing System
• 00812345027617: Cardiac Stress Testing System
• 00812345027600: Cardiac Stress Testing System
• 00812345027594: Cardiac Stress Testing System
• 00812345027587: Cardiac Stress Testing System
• 00812345027570: Cardiac Stress Testing System
• 00812345027563: Cardiac Stress Testing System
• 00817655023182: Cardiac Stress Testing System
• 00817655021935: Cardiac Stress Testing System
• 00817655021881: Cardiac Stress Testing System
• 00817655021355: Cardiac Stress Testing System
• 00817655021331: Cardiac Stress Testing System
• 00817655021119: Cardiac Stress Testing System
• 00817655020754: Cardiac Stress Testing System
• 00817655020075: Cardiac Stress Testing System