Q-Tel RMS

GUDID 00817655021454

Cardiac and pulmonary rehabilitation data acquisition and editing system

MORTARA INSTRUMENT, INC.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00817655021454
• NIH Device Record Key: a0736d1a-e982-427c-a0a8-404cde176065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Tel RMS
• Version Model Number: 33193-103-51
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817655021454 [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: 2017-05-03

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