CardioSoft 2006300-112

GUDID 00195278364661

CARDIOSOFT V7.0 SP7.2

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00195278364661
• NIH Device Record Key: 6d0b92b8-e9de-479a-9564-abc90216beae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioSoft
• Version Model Number: V7.0
• Catalog Number: 2006300-112
• 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: 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	00195278364661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231870

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: 2025-04-02
• Device Publish Date: 2025-03-25

On-Brand Devices [CardioSoft]

• 00840682105170: V6.73
• 00195278364661: CARDIOSOFT V7.0 SP7.2