RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER

GUDID 07290008960267

The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results.

SHL TELEMEDICINE INTERNATIONAL LTD.

Electrocardiograph, home-use

• Primary Device ID: 07290008960267
• NIH Device Record Key: 4752d3fc-7d8c-4d67-a947-b699a870c10e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
• Version Model Number: E-560-0 / E-561-0
• 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: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com
• Phone: +97235612212
• Email: info@shl-telemedicine.com

Device Dimensions

• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram
• Length: 90 Millimeter
• Width: 75 Millimeter
• Depth: 30 Millimeter
• Weight: 200 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290008960267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063609

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: 2023-08-30
• Device Publish Date: 2023-08-22

Devices Manufactured by SHL TELEMEDICINE INTERNATIONAL LTD.

• 07290008960267 - RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER: 2023-08-30The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results.
• 07290008960267 - RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER: 2023-08-30 The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG ex
• 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: 2019-02-06 The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smart