Zio monitor

GUDID 00869770000241

IRHYTHM TECHNOLOGIES, INC.

Electrocardiographic ambulatory recorder

• Primary Device ID: 00869770000241
• NIH Device Record Key: 6cfc8443-8c4a-44f9-b42c-f597d1d50bd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zio monitor
• Version Model Number: DFG0001
• Company DUNS: 861237670
• Company Name: IRHYTHM TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00869770000241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202359

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

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: 2022-05-11
• Device Publish Date: 2022-05-03

Devices Manufactured by IRHYTHM TECHNOLOGIES, INC.

• 00850043907046 - Zio ECG Utilization Software (ZEUS) System: 2024-08-05
• 00869770000241 - Zio monitor: 2022-05-11
• 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