CareLink SmartSync™ PSA Application

GUDID 00643169833753

SW D00U002 CARELINK SMARTSYNC PSA APP

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00643169833753
NIH Device Record Key32a9e825-7db7-4c24-8b27-215a89de45c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareLink SmartSync™ PSA Application
Version Model NumberD00U002
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
GS100643169833753 [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 Number5
Public Version Date2019-07-02
Device Publish Date2017-05-25

Devices Manufactured by MEDTRONIC, INC.

00199150050161 - NA2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
00199150050178 - NA2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E
00199150050185 - NA2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L
20199150050202 - NA2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK
00199150050871 - NA2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4
00763000877033 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15006X SPR LEG RX US M
00763000877040 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15010X SPR LEG RX US M
00763000877057 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15012X SPR LEG RX US M

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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