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.

20763000825212 - NA2024-03-25 CUSTOM PACK SS12B17R1 5PK CHANGEOUT
00763000825324 - NA2024-03-25 78.800
00763000940300 - NA2024-03-25 CUSTOM PACK BB6H26R45 ADULT CK
00763000941055 - NA2024-03-25 CUSTOM PACK HY9M47R20 ADLT MAIN
20763000941073 - NA2024-03-25 CUSTOM PACK BB12G07R 5PK ACC LINE
00763000941086 - NA2024-03-25 CUSTOM PACK BB12F62R2 UOFU HEART PA
00763000941093 - NA2024-03-25 CUSTOM PACK HY8B05R11 HBC
00763000941352 - NA2024-03-25 CUSTOM PACK BB12F31R E TRANS

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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