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Zio ECG Utilization Software (ZEUS) System

FDA UDI

Class II (US FDA UDI)

by Irhythm Technologies, Inc.

Identity

Trade Name
Zio ECG Utilization Software (ZEUS) System FDA UDI
Generic Name
Cardiopulmonary physiological parameter analysis software FDA UDI
Model / Reference
FG0401US FDA UDI

Identifiers

Primary DI / UDI-DI
00850043907046 FDA UDI
510(k) Number
K202527 FDA UDI
K222389 FDA UDI
FDA Product Code
DQK FDA UDI
DXH FDA UDI
DSI FDA UDI
GMDN Term
Cardiopulmonary physiological parameter analysis software FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary physiological parameter analysis software

Zio ECG Utilization Software (ZEUS) System by Irhythm Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary physiological parameter analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Irhythm Technologies, Inc.

Sources (1)

  • FDA UDI 641c34c3-b31d-449a-b2b0-50cd167d69e6 33 fields · synced Jun 8, 2026