Evera MRI™ S DR SureScan™

GUDID 00763000060015

ICD-DR DDMC3D1 EVERA MRI S US DF1

MEDTRONIC, INC.

Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator
Primary Device ID00763000060015
NIH Device Record Key1b81ee97-54a0-48e0-a0b8-cb5ff9391543
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvera MRI™ S DR SureScan™
Version Model NumberDDMC3D1
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]
GS100763000060015 [Primary]

FDA Product Code

NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable
NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Evera MRI™ S DR SureScan™]

00643169929258ICD-DR DDMC3D1 EVERA MRI S US DF1
00643169837744ICD-DR DDMC3D1 EVERA MRI S US DF1
00643169717244ICD-DR DDMC3D1 EVERA MRI S US DF1
00763000060015ICD-DR DDMC3D1 EVERA MRI S US DF1

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