Nonin Adapter Box Assy for Watch-PAT 200i AS2250304

GUDID 07290109222851

Nonin Adapter Box Assy WatchPAT200

ITAMAR MEDICAL LTD

Polysomnograph
Primary Device ID07290109222851
NIH Device Record Key595457e7-b23a-4c10-ad16-23e47c56e433
Commercial Distribution StatusIn Commercial Distribution
Brand NameNonin Adapter Box Assy for Watch-PAT 200i
Version Model NumberNonin Adapter Box Assy for Watch-PAT 200i
Catalog NumberAS2250304
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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal
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
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109222851 [Primary]

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 Date2018-07-06
Device Publish Date2016-09-07

On-Brand Devices [Nonin Adapter Box Assy for Watch-PAT 200i]

07290109222929Nonin Adapter Box Assy WP200 Bracelet Comp. (Recertified)
07290109222912Nonin Adapter Box Assy WatchPAT200 (Recertified)
07290109222868Nonin Adapter Box Assy WP200 Bracelet Comp.
07290109222851Nonin Adapter Box Assy WatchPAT200

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