ZIO AT Patch

FDA UDI

Class II (US FDA UDI)

by Irhythm Technologies, Inc.

Identity

Trade Name: ZIO AT Patch FDA UDI
Generic Name: Electrocardiographic ambulatory recorder FDA UDI
Device Name: ZIO AT ECG Monitoring Service FDA UDI
Model / Reference: A100A100X FDA UDI
Description: ZIO AT ECG Monitoring Service FDA UDI

Identifiers

Primary DI / UDI-DI: 00869770000210 FDA UDI
FDA Product Code: DQK FDA UDI
DSI FDA UDI
DXH FDA UDI
DSH FDA UDI
GMDN Term: Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
870.1025 FDA UDI
870.2920 FDA UDI
870.2800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiographic ambulatory recorder

ZIO AT Patch by Irhythm Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Irhythm Technologies, Inc.

Sources (1)

FDA UDI ab3a227f-ad23-48d7-a230-a23132346546 33 fields · synced Jun 8, 2026