Visia AF MRI™ S VR SureScan™

GUDID 00763000060107

ICD-VR DVFC3D1 VISIA AF MRI S US DF1

MEDTRONIC, INC.

Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator
Primary Device ID00763000060107
NIH Device Record Keyaccf37c8-22d4-4aaa-bea9-539e7809fdae
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisia AF MRI™ S VR SureScan™
Version Model NumberDVFC3D1
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
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [Primary]
GS100763000060107 [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 [Visia AF MRI™ S VR SureScan™]

00643169988651ICD DVFC3D4 VISIA AF S VR DF4 MRI US
00643169988644ICD DVFC3D4 VISIA AF S VR DF4 MRI US
00643169929944ICD-VR DVFC3D1 VISIA AF MRI S US DF1
00643169717206ICD-VR DVFC3D1 VISIA MRI S US DF1
00643169566446ICD-VR DVFC3D4 VISIA AF MRI S US DF4
00763000060107ICD-VR DVFC3D1 VISIA AF MRI S US DF1
00763000060060ICD-VR DVFC3D4 VISIA AF MRI S US DF4

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