DETECT®

GUDID 20613994755623

MAPPING TOOL 10650 LES TST DETECT 5P 26L

MEDTRONIC, INC.

External pacemaker, epicardial pacing
Primary Device ID20613994755623
NIH Device Record Keye5c0a0ea-dd20-4dd3-8e92-1fd854e3d9e6
Commercial Distribution Discontinuation2016-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDETECT®
Version Model Number10650
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 Kittrue
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994755629 [Primary]
GS120613994755623 [Package]
Contains: 00613994755629
Package: PK [5 Units]
Discontinued: 2016-08-09
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDFELECTRODE, PACEMAKER, TEMPORARY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-05
Device Publish Date2015-06-23

On-Brand Devices [DETECT®]

20613994755623MAPPING TOOL 10650 LES TST DETECT 5P 26L
00613994377890MAPPING TOOL 10650 LES TST DETECT 5P 18L

Trademark Results [DETECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DETECT
DETECT
98450936 not registered Live/Pending
Ambilabs, LLC
2024-03-15
DETECT
DETECT
97724801 not registered Live/Pending
JPI Healthcare Solutions, Inc
2022-12-20
DETECT
DETECT
97195109 not registered Live/Pending
Leverage Information Systems, Inc.
2021-12-29
DETECT
DETECT
97195062 not registered Live/Pending
Leverage Information Systems, Inc.
2021-12-29
DETECT
DETECT
90784566 not registered Live/Pending
Fortem Genus Inc.
2021-06-21
DETECT
DETECT
90639351 not registered Live/Pending
Detect, Inc.
2021-04-12
DETECT
DETECT
90590379 not registered Live/Pending
Detect, Inc.
2021-03-19
DETECT
DETECT
90298064 not registered Live/Pending
Homodeus, Inc.
2020-11-04
DETECT
DETECT
90052506 not registered Live/Pending
INVITAE CORPORATION
2020-07-14
DETECT
DETECT
88902307 not registered Live/Pending
The Broad Institute, Inc.
2020-05-05
DETECT
DETECT
87064300 5079962 Live/Registered
Leverage Information Systems, Inc.
2016-06-08
DETECT
DETECT
87064278 5079961 Live/Registered
Leverage Information Systems, Inc.
2016-06-08

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