MLCL Upgrade

GUDID 00840682188968

Upgrade Kit MLCL V7.1

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac electrophysiology analysis system

• Primary Device ID: 00840682188968
• NIH Device Record Key: 10e801b8-2003-401b-a6f3-0a3e8efe6844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MLCL Upgrade
• Version Model Number: BT21
• 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

Customer Support Contacts

• Phone: +1(800) 437-1171
• Email: xx@xx.xx
• Phone: +1(800) 437-1171
• Email: xx@xx.xx
• Phone: +1(800) 437-1171
• Email: xx@xx.xx
• Phone: +1(800) 437-1171
• Email: xx@xx.xx
• Phone: +1(800) 437-1171
• Email: xx@xx.xx
• Phone: +1(800) 437-1171
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682188968 [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: 2025-04-21
• Device Publish Date: 2020-06-12

On-Brand Devices [MLCL Upgrade]

• 00195278516015: Upgrade Kit MLCL V8.0
• 00840682188968: Upgrade Kit MLCL V7.1