WatchPAT ONE-M AC2110860

GUDID 07290109223032

WatchPAT ONE-M

ITAMAR MEDICAL LTD

Polysomnograph
Primary Device ID07290109223032
NIH Device Record Keya861d056-4be4-46d4-afdd-42ac9ae85242
Commercial Distribution StatusIn Commercial Distribution
Brand NameWatchPAT ONE-M
Version Model NumberWatchPAT ONE-M
Catalog NumberAC2110860
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109223032 [Primary]
GS107290109223049 [Package]
Package: carton [12 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-26
Device Publish Date2021-03-18

Devices Manufactured by ITAMAR MEDICAL LTD

07290109225227 - Accessories, EndoPATx2023-05-05 Accessories for EndoPATx
07290109225425 - EndoPATx2023-05-05 EndoPATx Device
07290109223377 - EndoPATx2023-05-05 EndoPATx Device
07290109223193 - Central Plus Sensor 2023-03-21 Central Plus Sensor for WatchPAT300
07290109223223 - WatchPAT ONE2023-03-21 WatchPAT ONE-M for Canada
07290109223230 - WatchPAT ONE 2023-03-21 WatchPAT ONE E for Canada
07290109223254 - WatchPAT ONE 2023-03-21 WatchPAT ONE for Canada
07290109222103 - 12 uPAT Probes for Watch-PAT2023-03-14 12 uPAT Probes

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