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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 07290008960359 [Primary] |
DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-02-06 |
Device Publish Date | 2019-01-06 |
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 | 2019-02-06The 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMARTHEART 86896543 not registered Live/Pending |
Veridian Healthcare, LLC 2016-02-03 |
SMARTHEART 86263520 not registered Dead/Abandoned |
Shaklee Corporation 2014-04-25 |
SMARTHEART 77930173 not registered Dead/Abandoned |
Normerica Inc. 2010-02-08 |
SMARTHEART 77362600 not registered Dead/Abandoned |
DROLSHAGEN, BRIDGET M. 2008-01-02 |
SMARTHEART 74526162 1990670 Dead/Cancelled |
HARLEY STREET SOFTWARE LTD. 1994-05-18 |