ComboLab 2300000-005

GUDID 00195278507051

Computer ComboLab Acquisition v8.0

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 00195278507051
• NIH Device Record Key: 54be045d-cf12-46f1-bbd3-44dbef74267b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComboLab
• Version Model Number: AltiX
• Catalog Number: 2300000-005
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278507051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213972

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: 2022-05-09
• Device Publish Date: 2022-05-01

On-Brand Devices [ComboLab]

• 00840682146029: A1
• 00840682123570: v6.9.6 R3
• 00195278507051: Computer ComboLab Acquisition v8.0
• 00195278935687: AltiX AI.i ComboLab Computer