CASE 2035123-001

GUDID 00195278403643

CASE V7.0

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: 00195278403643
• NIH Device Record Key: 0cc4542a-46ad-4828-a8da-c908c7a86982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CASE
• Version Model Number: V7.0
• Catalog Number: 2035123-001
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278403643 [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 [CASE]

• 00840682105088: V6.7
• 00195278617644: CASE V7 GENERIC ATO
• 00195278403643: CASE V7.0