XScribe

GUDID 00817655021997

Cardiac Stress Testing System

MORTARA INSTRUMENT, INC.

Cardiac stress exercise monitoring system

• Primary Device ID: 00817655021997
• NIH Device Record Key: 4c0656c3-3d18-4f79-aa4c-35b5b7e2f779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XScribe
• Version Model Number: XSCRIBE-6AA-AFAXB
• 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	00817655021997 [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: 2017-09-13

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