Accessories for Endo PAT 2000 AC0001600

GUDID 07290109225203

Accessories, EndoPAT2000

ITAMAR MEDICAL LTD

Cardiovascular-risk peripheral arterial tonometry system
Primary Device ID07290109225203
NIH Device Record Keye08dbaec-912a-44b2-9bfb-74a2ec164c02
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessories for Endo PAT 2000
Version Model NumberAccessories for Endo PAT 2000
Catalog NumberAC0001600
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 Numberfalse
Manufacturing Datefalse
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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109225203 [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 Date2016-09-06

Devices Manufactured by ITAMAR MEDICAL LTD

07290109225227 - Accessories, EndoPATx2023-05-05 Accessories for EndoPATx
07290109225425 - EndoPATx2023-05-05 EndoPATx Device
07290109223377 - EndoPATx2023-05-05 EndoPATx Device
07290109223193 - Central Plus Sensor 2023-03-21 Central Plus Sensor for WatchPAT300
07290109223223 - WatchPAT ONE2023-03-21 WatchPAT ONE-M for Canada
07290109223230 - WatchPAT ONE 2023-03-21 WatchPAT ONE E for Canada
07290109223254 - WatchPAT ONE 2023-03-21 WatchPAT ONE for Canada
07290109222103 - 12 uPAT Probes for Watch-PAT2023-03-14 12 uPAT Probes

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