ZIO AT Patch

GUDID 00869770000210

ZIO AT ECG Monitoring Service

IRHYTHM TECHNOLOGIES, INC.

Electrocardiographic ambulatory recorder

• Primary Device ID: 00869770000210
• NIH Device Record Key: ab3a227f-ad23-48d7-a230-a23132346546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIO AT Patch
• Version Model Number: A100A100X
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869770000210 [Primary]

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-04-23

Devices Manufactured by IRHYTHM TECHNOLOGIES, INC.

• 00869770000241 - Zio monitor: 2022-05-11
• 00869770000210 - ZIO AT Patch: 2019-11-08ZIO AT ECG Monitoring Service
• 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