Q-Stress

Basic Information

• Brand Name: Q-Stress
• Primary DI: 00817655021119
• Version / Model: QS-6HD-AXAAA
• Company Name: MORTARA INSTRUMENT, INC.
• Labeler DUNS: 062046149
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-14
• Public Version: 4
• Public Version Date: 2020-06-29
• Public Version Status: Update
• Public Device Record Key: e23a5b0f-f1b5-4782-8984-0cc872d2adf9

Device Description

Cardiac Stress Testing System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36145	Cardiac stress exercise monitoring system	An assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a predetermined kind, e.g., an ergometer. The system will typically analyse the recorded data, display results, monitor various functions, provide control of the workload, and give printouts, providing the clinician with a complete representation of the electrical activity of the heart, including heart rate.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817655021119	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K001492	000
K082173	000
K152944	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: – 149 Degrees Fahrenheit