AccessGUDID - DEVICE: MoMe® ARC (B690MA10)

GUDID

Device Identifier (DI) Information

Brand Name: MoMe® ARC
Version or Model: 30000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Infobionic, Inc.

Primary DI Number: B690MA10
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2029
Device Count: 1
Labeler D-U-N-S® Number*: 078650138 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37176	Patient monitoring system module, electrocardiographic, telemetric	A small unit dedicated for the receipt of wireless electrocardiogram (ECG) signals sent from an ambulatory patient so that the electrical activity of the patient's heart can be monitored when the patient is remote to the patient monitoring system. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG signal information received and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSI	Detector And Alarm, Arrhythmia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230265	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e55f7069-767f-4ec9-b65a-3f520430cad8
Public Version Date: January 05, 2024
Public Version Number: 2
DI Record Publish Date: December 28, 2023