Watch-PAT300 AS2110701

GUDID 07290109222462

Watch-PAT300 Device

ITAMAR MEDICAL LTD

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph
Primary Device ID07290109222462
NIH Device Record Key5b3c92b9-0d9a-4af9-b7f2-93ec535ced27
Commercial Distribution StatusIn Commercial Distribution
Brand NameWatch-PAT300
Version Model NumberWatch-PAT300
Catalog NumberAS2110701
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
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com
Phone+97246177000
Emailinfo@itamar-medical.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109222141 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222158 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222165 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222172 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222226 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222233 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222240 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222257 [Package]
Package: [1 Units]
In Commercial Distribution
GS107290109222455 [Primary]
GS107290109222462 [Package]
Contains: 07290109222455
Package: carton [1 Units]
In Commercial Distribution
GS107290109222554 [Package]
Package: carton [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVentilatory Effort Recorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-06
Device Publish Date2019-06-30

On-Brand Devices [Watch-PAT300]

07290109222417Watch-PAT300 Device
07290109222462Watch-PAT300 Device
07290109222486Watch-PAT300 Device
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