Portrait CVAXB 5863721-12

GUDID 00198953024096

Portrait Central Viewer Application Installer V1.2.0

Ge Medical Systems Information Technologies, Inc.

Wireless patient monitor/sensor reporting software, professional-only

• Primary Device ID: 00198953024096
• NIH Device Record Key: 08fd1446-2d06-4374-a650-53137643de05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portrait CVAXB
• Version Model Number: CVAXB
• Catalog Number: 5863721-12
• Company DUNS: 118935631
• 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	00198953024096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234130

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without 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: 2025-12-18
• Device Publish Date: 2025-12-10

On-Brand Devices [Portrait CVAXB]

• 00195278656681: Portrait Central Viewer Application Installer v1.1.0
• 00198953024096: Portrait Central Viewer Application Installer V1.2.0