← Back to catalogue

MoMe® ARC

FDA UDI

Class II (US FDA UDI)

by Infobionic, Inc.

Identity

Trade Name
MoMe® ARC FDA UDI
Generic Name
Patient monitoring system module, electrocardiographic, telemetric FDA UDI
Device Name
MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link. The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway. FDA UDI
Model / Reference
30000 FDA UDI
Description
MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link. The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway. FDA UDI

Identifiers

Primary DI / UDI-DI
B690MA10 FDA UDI
510(k) Number
K230265 FDA UDI
FDA Product Code
DSI FDA UDI
GMDN Term
Patient monitoring system module, electrocardiographic, telemetric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Patient monitoring system module, electrocardiographic, telemetric

MoMe® ARC by Infobionic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electrocardiographic, telemetric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Infobionic, Inc.

Sources (1)

  • FDA UDI e55f7069-767f-4ec9-b65a-3f520430cad8 36 fields · synced May 30, 2026