Central Plus Sensor for Watch-PAT200U UC3000100

GUDID 07290109222080

Central Plus Sensor, Replacement - US

ITAMAR MEDICAL LTD

Polysomnograph
Primary Device ID07290109222080
NIH Device Record Keydc776828-3d2e-4065-823d-5423153b33c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentral Plus Sensor for Watch-PAT200U
Version Model NumberCentral Plus Sensor for Watch-PAT200U
Catalog NumberUC3000100
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
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 Atmospheric PressureBetween 68.95 KiloPascal and 103.42 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109222080 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-16
Device Publish Date2018-06-14

On-Brand Devices [Central Plus Sensor for Watch-PAT200U]

07290109222097Central Plus Sensor, Replacement - Euro
07290109222080Central Plus Sensor, Replacement - US
07290109222073Central Plus Sensor, Replacement - Euro
07290109222035Central Plus Sensor for WatchPAT products, Replacement

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