PACEART OPTIMA™ System

GUDID 00643169552296

SW POS12D15 MKT GLBL

MEDTRONIC, INC.

Patient health record information system application software Patient health record information system application software
Primary Device ID00643169552296
NIH Device Record Key00d6411a-0c99-489e-8de5-7d2458d2b0c6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePACEART OPTIMA™ System
Version Model NumberPOS12D15
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

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169552296 [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 Date2016-04-01

On-Brand Devices [PACEART OPTIMA™ System]

00643169956810SW POS12D17 OPTIMA 1.7 GLOBAL
00643169956803SW POS12D17 OPTIMA 1.7 GLOBAL
00643169707351SW POS12D16 MKT GLBL
00643169552296SW POS12D15 MKT GLBL
00643169463523SW POS12D14 PACEART OPTIMA MKT GLBL
00643169411296SW POS12D13 PACEART OPTIMA MKT GLBL
00643169345058SW POS12D13 PACEART OPTIMA MKT GLBL
00763000083342SW POS12D18 OPTIMA 1.8 GLOBAL

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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