Mural Clinical Viewer

GUDID 00195278789846

MD Mural Clinical Viewer 1.2 MEDICAL DEVICE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system

• Primary Device ID: 00195278789846
• NIH Device Record Key: 6de70a8e-54e8-473a-925e-c8c3258abd57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mural Clinical Viewer
• Version Model Number: 1.2
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278789846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222586

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [Mural Clinical Viewer]

• 00195278577559: MD Mural Clinical Viewer MEDICAL DEVICE
• 00195278789846: MD Mural Clinical Viewer 1.2 MEDICAL DEVICE