AccessGUDID - DEVICE: smartheart (07290008960359)

GUDID

Device Identifier (DI) Information

Brand Name: smartheart
Version or Model: 3.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHL TELEMEDICINE INTERNATIONAL LTD.

Primary DI Number: 07290008960359
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531817906 *Terms of Use

Device Description: The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smartheart acquires EGG data via attached electrodes. The smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.

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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113514	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 Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: belt/ 32 cm
Height: 1.5 Centimeter
Width: 8.5 Centimeter
Length: 11 Centimeter
Weight: 110 Gram

Device Record Status

Public Device Record Key: 7599ae3c-ef76-47af-bde9-12a7e0e5b8c2
Public Version Date: August 23, 2023
Public Version Number: 3
DI Record Publish Date: January 06, 2019