GUDID 00643169725126

EPG 5392 MKT USA MOLDED CASE

MEDTRONIC, INC.

External pacemaker, epicardial pacing
Primary Device ID00643169725126
NIH Device Record Key71a64009-624f-4c1c-b002-043242e4c73d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5392
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 Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169725126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTEPULSE-GENERATOR, PACEMAKER, EXTERNAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-05
Device Publish Date2017-01-29

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