Endo PAT 2000 US1650004

GUDID 07290109225357

Endo PAT 2000 Device

ITAMAR MEDICAL LTD

Cardiovascular-risk peripheral arterial tonometry system
Primary Device ID07290109225357
NIH Device Record Keya239614a-dc72-407f-9b15-323133c70de8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo PAT 2000
Version Model NumberEndo PAT 2000
Catalog NumberUS1650004
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 TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109225319 [Package]
Package: carton [1 Units]
In Commercial Distribution
GS107290109225333 [Package]
Package: carton [1 Units]
In Commercial Distribution
GS107290109225357 [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 Date2016-09-05

On-Brand Devices [Endo PAT 2000]

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

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