CareLink Express™ Mobile System

GUDID 00643169545526

SW 31301 CARELINK EXPRESS MOBILE USA

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00643169545526
NIH Device Record Keye3b3a4cc-83e9-471a-b631-ecae58559379
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareLink Express™ Mobile System
Version Model Number31301
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
GS100643169545526 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-25

On-Brand Devices [CareLink Express™ Mobile System]

00643169636668SW 31302 CARELINK EXPRESS MOBILE IOS USA
00643169545526SW 31301 CARELINK EXPRESS MOBILE USA

Trademark Results [CareLink Express]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARELINK EXPRESS
CARELINK EXPRESS
85213818 4195373 Live/Registered
Medtronic, Inc.
2011-01-10

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