MoMe® Kardia

GUDID B690MK10

MoMe® Kardia 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. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.

INFOBIONIC, INC.

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• Primary Device ID: B690MK10
• NIH Device Record Key: eddf3e53-8cc4-4f53-96f7-f21aa96a65b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoMe® Kardia
• Version Model Number: 01854
• 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: false
• Serial Number: true
• 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	B690MK10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160064

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-07
• 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: 2019-05-07MoMe® Kardia 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. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
• 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: 2018-10-24 MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes