Globe® Controller

GUDID 07540162100215

Kardium Inc

Cardiac mapping system

• Primary Device ID: 07540162100215
• NIH Device Record Key: 507a4309-747e-4dd7-b862-112a9e2bcae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Globe® Controller
• Version Model Number: 601-00048
• Company DUNS: 248480043
• Company Name: Kardium 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	07540162100215 [Package]; Contains: 07540162100291; Package: [1 Units]; In Commercial Distribution
GS1	07540162100291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250747

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: 2025-09-23
• Device Publish Date: 2025-09-15

Devices Manufactured by Kardium Inc

• 07540162100154 - Globe® Catheter: 2025-09-23
• 07540162100192 - Globe® Introducer: 2025-09-23
• 07540162100246 - Globe Positioning System (GPS™) Cable: 2025-09-23
• 07540162100260 - Globe Positioning System (GPS™) Electrodes: 2025-09-23
• 07540162100284 - Globe® Catheter Cable: 2025-09-23
• 07540162100215 - Globe® Controller: 2025-09-23
• 07540162100215 - Globe® Controller: 2025-09-23
• 07540162100314 - Globe® Workstation: 2025-09-23
• 07540162100222 - Globe® PF Generator: 2025-09-23