CardioLab 2400000-004

GUDID 00195278935656

AltiX AI.i CardioLab Computer

Ge Medical Systems Information Technologies, Inc.

Cardiac electrophysiology analysis system

• Primary Device ID: 00195278935656
• NIH Device Record Key: fb098b5d-01b9-44d2-95cb-8fc0cfa68abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioLab
• Version Model Number: AltiX AI.i
• Catalog Number: 2400000-004
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00195278935656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243540

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2025-05-13
• Device Publish Date: 2025-05-05

On-Brand Devices [CardioLab]

• 00840682146012: A1
• 00840682123549: v6.9.6 R3
• 00840682119689: Simulator-Internal
• 00840682119641: Simulator
• 00195278507044: Computer CardioLab Acquisition v8.0
• 00195278935656: AltiX AI.i CardioLab Computer