Paceart Optima™ System 1.6 with Analytics

GUDID 00643169876927

SW POS12D16A OPTIMA 1.6 WITH ANALYTICS

MEDTRONIC, INC.

Patient health record information system application software Patient health record information system application software
Primary Device ID00643169876927
NIH Device Record Keyecd8a224-dde1-4f74-aafc-c95c36c9eaaa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaceart Optima™ System 1.6 with Analytics
Version Model NumberPOS12D16A
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Batchtrue
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+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169876927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSELECTROCARDIOGRAPH

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-16

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Trademark Results [Paceart Optima]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PACEART OPTIMA
PACEART OPTIMA
77751962 4222183 Live/Registered
Medtronic, Inc.
2009-06-04

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