CLAB II Plus Amplifier

GUDID 00840682119634

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 00840682119634
• NIH Device Record Key: 330854c5-b3fd-421f-8a75-5626d5d63f4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLAB II Plus Amplifier
• Version Model Number: 64 Channel
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682119634 [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: 2016-07-03

On-Brand Devices [CLAB II Plus Amplifier]

• 00840682119634: 64 Channel
• 00840682119603: 128 Channel