AccessGUDID - DEVICE: MoMe® Kardia (B690MK10)

GUDID

Device Identifier (DI) Information

Brand Name: MoMe® Kardia
Version or Model: 01854
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Infobionic, Inc.

Primary DI Number: B690MK10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078650138 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
36367	Electrocardiography telemetric monitoring system transmitter	A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DSI	Detector And Alarm, Arrhythmia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160064	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: eddf3e53-8cc4-4f53-96f7-f21aa96a65b4
Public Version Date: November 16, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2018