Endo PAT 2000 AS1650030

GUDID 07290109225364

EndoPAT2000 Device

ITAMAR MEDICAL LTD

Cardiovascular-risk peripheral arterial tonometry system
Primary Device ID07290109225364
NIH Device Record Key46711195-8b89-4d62-8c0b-c8f82042e75b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo PAT 2000
Version Model NumberEndo PAT 2000
Catalog NumberAS1650030
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 TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius
Handling Environment TemperatureBetween 22 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109225364 [Package]
Contains: 07290109225371
Package: carton [1 Units]
In Commercial Distribution
GS107290109225371 [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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