Mac-Lab 2400000-003

GUDID 00195278935632

AltiX AI.i Mac-Lab Computer

Ge Medical Systems Information Technologies, Inc.

Cardiac catheterization monitoring system

• Primary Device ID: 00195278935632
• NIH Device Record Key: 4d608dd4-c640-4816-9a31-3aa5ddff0ed8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mac-Lab
• Version Model Number: AltiX AI.i
• Catalog Number: 2400000-003
• 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	00195278935632 [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 [Mac-Lab]

• 00840682145985: A1
• 00840682123556: v6.9.6 R3
• 00195278935632: AltiX AI.i Mac-Lab Computer