MoMe® Software Platform

GUDID B690MS10

MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embed

INFOBIONIC, INC.

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: B690MS10
• NIH Device Record Key: 0cc0d4fb-af2b-47e4-baf1-3c506077977e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoMe® Software Platform
• Version Model Number: 1400
• Company DUNS: 078650138
• Company Name: INFOBIONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B690MS10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152491

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-24
• Device Publish Date: 2018-09-23

Devices Manufactured by INFOBIONIC, INC.

• B690MA10 - MoMe® ARC: 2024-01-05 MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patie
• B690MK10 - MoMe® Kardia: 2019-05-07 MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in pa
• B690MS10 - MoMe® Software Platform: 2018-10-24MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embed
• B690MS10 - MoMe® Software Platform: 2018-10-24 MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes