MEDTRONIC CARELINK EXPRESS™

GUDID 00613994952400

MON 2020B1 CARELINK USA EXPRESS MONITOR

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00613994952400
NIH Device Record Key1510cd69-ac72-49de-8feb-1360a4b44b82
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDTRONIC CARELINK EXPRESS™
Version Model Number2020B1
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 TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994952400 [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 Date2014-10-09

On-Brand Devices [MEDTRONIC CARELINK EXPRESS™]

00613994952431MON 2020C1 CARELINK USA EXPRESS MONITOR
00613994952400MON 2020B1 CARELINK USA EXPRESS MONITOR
00643169107052MON 2020B2 CARELINK USA MR4 MONITOR
00643169312081MON 2020C2 CARELINK 60601 3ED USA
00643169192058MON 2020B3 CARELINK USA BW 60601

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