XScribe

GUDID 00817655022543

Cardiac Stress Testing System

MORTARA INSTRUMENT, INC.

Cardiac stress exercise monitoring system

• Primary Device ID: 00817655022543
• NIH Device Record Key: 86d4699a-b307-4d3b-961e-33998f60f5ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XScribe
• Version Model Number: XSCRIBE-6AC-AAAXX
• 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 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817655022543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022618

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: 2017-10-12

On-Brand Devices [XScribe]

• 00812345029987: Cardiac Stress Testing System
• 00812345027556: Cardiac Stress Testing System
• 00812345027549: Cardiac Stress Testing System
• 00812345027532: Cardiac Stress Testing System
• 00812345027525: Cardiac Stress Testing System
• 00812345027518: Cardiac Stress Testing System
• 00812345027501: Cardiac Stress Testing System
• 00812345027495: Cardiac Stress Testing System
• 00812345027488: Cardiac Stress Testing System
• 00812345027471: Cardiac Stress Testing System
• 00817655022543: Cardiac Stress Testing System
• 00817655022536: Cardiac Stress Testing System
• 00817655022215: Cardiac Stress Testing System
• 00817655022154: Cardiac Stress Testing System
• 00817655021997: Cardiac Stress Testing System
• 00817655021980: Cardiac Stress Testing System
• 00817655021836: Cardiac Stress Testing System
• 00817655021287: Cardiac Stress Testing System
• 00817655020730: Cardiac Stress Testing System
• 00817655020723: Cardiac Stress Testing System
• 00817655020648: Cardiac Stress Testing System
• 00817655020082: Cardiac Stress Testing System