MEDTRONIC CARELINK® MONITOR

GUDID 00643169376823

MON 2490C16 USA C16 HPMRI

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00643169376823
NIH Device Record Keyb1434592-4095-4577-b858-6f62b5b45fad
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMEDTRONIC CARELINK® MONITOR
Version Model Number2490C16
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 Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169376823 [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 Number4
Public Version Date2018-07-06
Device Publish Date2015-09-21

On-Brand Devices [MEDTRONIC CARELINK® MONITOR]

00643169690943MON 2490C17 CARELINK C17 VISIA CRTD USA
00643169376823MON 2490C16 USA C16 HPMRI
00643169341050MON 2490C15 CL 60601 3 ED HCM USA RFB
00643169334717MON 2490C15 CL 60601 3 ED LCM USA RFB
00643169191815MON 2490C15 USA C15 60601

Trademark Results [MEDTRONIC CARELINK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDTRONIC CARELINK
MEDTRONIC CARELINK
78416067 2990678 Live/Registered
Medtronic, Inc.
2004-05-10
MEDTRONIC CARELINK
MEDTRONIC CARELINK
78184734 2766910 Live/Registered
Medtronic, Inc.
2002-11-13
MEDTRONIC CARELINK
MEDTRONIC CARELINK
78071510 2722626 Live/Registered
MEDTRONIC INC.
2001-06-28

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