AccessGUDID - DEVICE: ECG Check (B287ECG01U0)

GUDID

Device Identifier (DI) Information

Brand Name: ECG Check
Version or Model: ECG01-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ECG01-Universal
Company Name: CARDIAC DESIGNS INC.

Primary DI Number: B287ECG01U0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079693152 *Terms of Use

Device Description: The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server. Specifically, the EGG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: * Skipped Beats * Pounding Heart (Palpitations) * Heart Racing or Irregular Pulse * Lightheadedness or Faintness * History of Arrhythmias Prescription

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):	Yes
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?
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXH	Transmitters And Receivers, Electrocardiograph, Telephone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122184	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
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 10d65149-371d-4294-b0fc-bba278c7de92
Public Version Date: November 10, 2021
Public Version Number: 5
DI Record Publish Date: September 28, 2016