Endo PAT 2000 US1650030

GUDID 07290109225388

Endo PAT 2000 Device

ITAMAR MEDICAL LTD

Cardiovascular-risk peripheral arterial tonometry system
Primary Device ID07290109225388
NIH Device Record Key32ff379c-7266-4f3e-bea1-931f94130696
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo PAT 2000
Version Model NumberEndo PAT 2000
Catalog NumberUS1650030
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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109225388 [Package]
Contains: 07290109225395
Package: carton [1 Units]
In Commercial Distribution
GS107290109225395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-12-31

On-Brand Devices [Endo PAT 2000]

07290109225388Endo PAT 2000 Device
07290109225364EndoPAT2000 Device
07290109225357Endo PAT 2000 Device
07290109225340EndoPAT2000 Device

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