CareLink SmartSync™ Percepta Serena Solara Application

GUDID 00763000002046

SW D00U004 SS PERCEPTA SERENA SOLERA

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00763000002046
NIH Device Record Key17e7aa59-ea67-4bed-80c4-86ce47eaf82f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareLink SmartSync™ Percepta Serena Solara Application
Version Model NumberD00U004
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000002046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-13

Devices Manufactured by MEDTRONIC, INC.

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20199150021134 - NA2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
00199150021147 - NA2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
20199150021165 - NA2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
20199150021653 - NA2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE

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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