CareLink SmartSync™ Azure Astra Application

GUDID 00763000002039

SW D00U003 SS AZURE ASTRA

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00763000002039
NIH Device Record Key7797dacb-23d2-44fe-989a-2d437c3d9e65
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareLink SmartSync™ Azure Astra Application
Version Model NumberD00U003
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
GS100763000002039 [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 Number2
Public Version Date2019-07-02
Device Publish Date2019-04-06

Devices Manufactured by MEDTRONIC, INC.

00199150025381 - NA2025-06-27 CUSTOM PACK BB11P25R3 VCH CENT V A
20199150025521 - NA2025-06-27 CUSTOM PACK BB9G37R2 5PK L VD AC
00199150026326 - NA2025-06-27 CUSTOM PACK BB11Z33R8 ALINA CPB
00199150026579 - NA2025-06-27 CUSTOM PACK BB5722R48 CHRT INF
00199150026692 - NA2025-06-27 CUSTOM PACK BB8R73R14 NH ADULT PACK
00199150026715 - NA2025-06-27 CUSTOM PACK BB6M71R12 CP PRIME
00199150026746 - NA2025-06-27 CUSTOM PACK BB7A25R12 PED
00199150026753 - NA2025-06-27 CUSTOM PACK BB12E34R4 SUPPORT PACK

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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