Watch-PAT200U US2150502

GUDID 07290109222899

Watch-PAT200U Device (EU)

ITAMAR MEDICAL LTD

Polysomnograph
Primary Device ID07290109222899
NIH Device Record Key2fa5d8b8-0b10-4f3a-bac0-f0ad9ee288a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameWatch-PAT200U
Version Model NumberWatch-PAT200U
Catalog NumberUS2150502
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109222493 [Package]
Package: box [1 Units]
In Commercial Distribution
GS107290109222899 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-05-23

On-Brand Devices [Watch-PAT200U]

07290109222899Watch-PAT200U Device (EU)
07290109222844Watch-PAT200U Device (EU)
07290109222738Watch-PAT200U Device
07290109222691Watch-PAT200U Device
07290109222646Watch-PAT200U Device
07290109222523Watch-PAT200U Device

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