Zio ECG Utilization Software (ZEUS) System

GUDID 00850043907046

IRHYTHM TECHNOLOGIES, INC.

Cardiac electrophysiology processing software

• Primary Device ID: 00850043907046
• NIH Device Record Key: 641c34c3-b31d-449a-b2b0-50cd167d69e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zio ECG Utilization Software (ZEUS) System
• Version Model Number: FG0401US
• Company DUNS: 861237670
• Company Name: IRHYTHM 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: 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	00850043907046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202527

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: 2024-08-05
• Device Publish Date: 2024-07-26

Devices Manufactured by IRHYTHM TECHNOLOGIES, INC.

• 00850043907046 - Zio ECG Utilization Software (ZEUS) System: 2024-08-05
• 00850043907046 - Zio ECG Utilization Software (ZEUS) System: 2024-08-05
• 00869770000241 - Zio monitor: 2022-05-11
• 00869770000210 - ZIO AT Patch: 2019-11-08 ZIO AT ECG Monitoring Service
• 00869770000203 - ZIO XT Patch: 2019-11-08 ZIO XT ECG Monitoring Service
• 00869770000234 - ZIO SR Patch: 2019-11-08 ZIO SR ECG Monitoring Service