EndoPATx AS1650007

GUDID 07290109225425

EndoPATx Device

ITAMAR MEDICAL LTD

Cardiovascular-risk peripheral arterial tonometry system
Primary Device ID07290109225425
NIH Device Record Keya16f96c3-fa38-4c73-ba25-2c248be5b54e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoPATx
Version Model NumberEndoPATx
Catalog NumberAS1650007
Company DUNS531857076
Company NameITAMAR MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com
Phone+97246177000
Emailinfousa@zoll.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109223353 [Package]
Package: carton [1 Units]
In Commercial Distribution
GS107290109225425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-05
Device Publish Date2023-04-27

On-Brand Devices [EndoPATx]

07290109223377EndoPATx Device
07290109225425EndoPATx Device

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.