PACEART® SYSTEM GET CONNECTED III

GUDID 00643169357730

SW PASDEVU3 DEV UPDATE MKT GLBL

MEDTRONIC, INC.

Patient health record information system application software
Primary Device ID00643169357730
NIH Device Record Key098b0758-2f27-4f71-9250-2e5cb3af93a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePACEART® SYSTEM GET CONNECTED III
Version Model NumberPASDEVU3
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 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169357730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

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® SYSTEM GET CONNECTED III]

00613994845801SW PASDEVUGCIII PACEART GLBL MR V 2.0
00613994533364SW PASCLGCIII PACEART GLBL MR GCIII
00613994533333SW PASDEMOGCIII PACEART GLBL MR GCIII
00613994533319SW PASDOCGCIII PACEART GLBL MR GCIII
00613994533302SW PASEXPGCIII PACEART GLBL MR GCIII
00613994533296SW PASGATEGCIII PACEART GLBL MR GCIII
00613994533272SW PASSATGCIII PACEART GLBL MR GCIII
00613994533265SW PASTCGCIII PACEART GLBL MR GCIII
00613994533241SW PASTMGCIII PACEART GLBL MR GCIII
00643169357730SW PASDEVU3 DEV UPDATE MKT GLBL

Trademark Results [PACEART]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PACEART
PACEART
87252084 5195774 Live/Registered
Medtronic, Inc.
2016-11-30
PACEART
PACEART
74074454 1650680 Live/Registered
Paceart, Inc.
1990-07-02

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