GUDID 00613994618184

EXT KIT 6985M INTL US

MEDTRONIC, INC.

Pacing/defibrillation lead electrical extension adaptor
Primary Device ID00613994618184
NIH Device Record Key10b50121-576d-4420-b5d9-4be93ba1fb07
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number6985M
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 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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 Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994618184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTDpacemaker lead Adaptor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-06-10

Devices Manufactured by MEDTRONIC, INC.

00763000994198 - N/A2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR
00199150065684 - NA2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM
00199150065691 - NA2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E
00199150065745 - NA2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED
20199150065763 - NA2026-01-06 CUSTOM PACK BB11V27R2 10PK ACC 3/8 CONN
00199150065844 - NA2026-01-06 CUSTOM PACK BB6Y04R14 EVL ADULT 3/8
00199150065851 - NA2026-01-06 CUSTOM PACK BB12P20R7 EVL ADLT SUPP
20199150065992 - NA2026-01-06 CUSTOM PACK 12S61R2 5PK EVL VCH PROCUR

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.