smartheart

GUDID 07290008960359

The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smartheart acquires EGG dat

SHL TELEMEDICINE INTERNATIONAL LTD.

Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use

• Primary Device ID: 07290008960359
• NIH Device Record Key: 7599ae3c-ef76-47af-bde9-12a7e0e5b8c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: smartheart
• Version Model Number: 3.3
• Company DUNS: 531817906
• Company Name: SHL TELEMEDICINE INTERNATIONAL LTD.
• 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: true
• 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

Customer Support Contacts

• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com
• Phone: 1866-745-8356
• Email: support.USA@smartheartpro.com

Device Dimensions

• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram
• Device Size Text, specify: 0
• Height: 1.5 Centimeter
• Width: 8.5 Centimeter
• Length: 11 Centimeter
• Weight: 110 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290008960359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113514

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-06
• Device Publish Date: 2019-01-06

Devices Manufactured by SHL TELEMEDICINE INTERNATIONAL LTD.

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• 07290008960427 - CARDIO MONITOR CENTER VISION: 2023-08-30 The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal compu
• 07290008960250 - CardioSen'C: 2023-08-29 The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere an
• 07290008960359 - smartheart: 2019-02-06The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smartheart acquires EGG dat
• 07290008960359 - smartheart: 2019-02-06 The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smart