MyCareLink Smart™

GUDID 00643169527539

MON 25000 MYCARELINK SMART US

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00643169527539
NIH Device Record Keyff87c0c3-cfb0-4aef-b89c-870340e03aac
Commercial Distribution Discontinuation2019-01-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMyCareLink Smart™
Version Model Number25000
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 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169527539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMHCONTAINER, SPECIMEN, STERILE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-13
Device Publish Date2015-02-24

On-Brand Devices [MyCareLink Smart™]

00643169666320MON 25000 MCL SMART 2.1 US
00643169569744MON 25000 MYCARELINK SMART US
00643169527539MON 25000 MYCARELINK SMART US
00763000305079MON 25000 MCL SMART 2.1 USA

Trademark Results [MyCareLink Smart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYCARELINK SMART
MYCARELINK SMART
86178859 4918670 Live/Registered
Medtronic, Inc.
2014-01-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.