GUDID 00613994371751

BOARD D4PCIUGCII PACEART DIALOGIC V/SPCH

MEDTRONIC, INC.

Patient health record information system application software
Primary Device ID00613994371751
NIH Device Record Key8d604fcd-8762-4da2-b194-d94477b3f8c9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberD4PCIUGCII
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994371751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

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 Date2016-04-01

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