AccessGUDID - DEVICE: KardiaMobile Card (B210AC0210)

GUDID

Device Identifier (DI) Information

Brand Name: KardiaMobile Card
Version or Model: AC-021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alivecor, Inc.

Primary DI Number: B210AC0210
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078523613 *Terms of Use

Device Description: The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms.

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?
11413	Electrocardiograph, professional, single-channel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.	Active	false
62641	Electrocardiograph, home-use	A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXH	Transmitters And Receivers, Electrocardiograph, Telephone
DPS	Electrocardiograph
QDA	Electrocardiograph Software For Over-The-Counter Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211668	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
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 76 and 101 KiloPascal
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78229898-52ad-4c37-be41-5d7389d0c126
Public Version Date: July 21, 2022
Public Version Number: 1
DI Record Publish Date: July 13, 2022