CareLink SmartSync™ Common Application

GUDID 00643169833715

SW M01G02 CARELINK SMARTSYNC ANDROID

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00643169833715
NIH Device Record Key92c56ef0-8ebd-44da-bdf7-5253b4c76883
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareLink SmartSync™ Common Application
Version Model NumberM01G02
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
GS100643169833715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTCANALYZER, PACEMAKER GENERATOR FUNCTION

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 Date2017-05-25

On-Brand Devices [CareLink SmartSync™ Common Application]

00643169833739SW M01A02 CARELINK SMARTSYNC IOS
00643169833715SW M01G02 CARELINK SMARTSYNC ANDROID

Trademark Results [CareLink SmartSync]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARELINK SMARTSYNC
CARELINK SMARTSYNC
86909270 not registered Live/Pending
Medtronic, Inc.
2016-02-16

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