GUDID 00681490153621

ACCESS 6984M EXTENDER BIP IS-1

MEDTRONIC, INC.

Pacing/defibrillation lead electrical extension adaptor
Primary Device ID00681490153621
NIH Device Record Key38df3bb0-a28f-4e3b-8878-acf5c2c373be
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6984M
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 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
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
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
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 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490153621 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-06-10

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