Portrait CSSXB 5973340

GUDID 00195278990914

PORTRAIT CORE SERVICES SOFTWARE V1.2.0

Ge Medical Systems Information Technologies, Inc.

Bedside information system application software

• Primary Device ID: 00195278990914
• NIH Device Record Key: b23ba5e2-407a-49b7-b7a1-09bade7c45e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portrait CSSXB
• Version Model Number: CSSXB
• Catalog Number: 5973340
• 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	00195278990914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234130

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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 CSSXB]

• 00195278659446: PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
• 00195278990914: PORTRAIT CORE SERVICES SOFTWARE V1.2.0