Q-Tel RMS

GUDID 00812345029871

Cardiac and pulmonary rehabilitation data acquisition and editing system

MORTARA INSTRUMENT, INC.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 00812345029871
• NIH Device Record Key: a59f11d4-f9a5-4c84-b02c-3138086b0f8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Tel RMS
• Version Model Number: 33193-103-50
• 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: 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
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• 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 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345029871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003576

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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 [Q-Tel RMS]

• 00812345029895: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029888: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029871: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029642: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029635: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029628: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029611: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029604: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029598: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029581: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029574: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029567: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029550: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029543: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029536: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029529: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029512: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029505: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029499: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00812345029482: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00817655021454: Cardiac and pulmonary rehabilitation data acquisition and editing system
• 00817655021447: Software accessory cleared with Q-Tel RMS
• 00817655021430: Software accessory cleared with Q-Tel RMS
• 00817655020105: Software accessory cleared with Q-Tel RMS