Mac-Lab

GUDID 00840682123556

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 00840682123556
• NIH Device Record Key: e672ae60-6306-441c-91e8-8a51584c5103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mac-Lab
• Version Model Number: v6.9.6 R3
• Company DUNS: 784985108
• 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	00840682123556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130626

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-11

On-Brand Devices [Mac-Lab]

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