Compia MRI™ CRT-D SureScan™

GUDID 00763000060091

CRTD DTMC1D1 COMPIA MRI US DF1

MEDTRONIC, INC.

Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator
Primary Device ID00763000060091
NIH Device Record Keya8c398fc-f22b-4fa5-b22a-b837f5eb20a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompia MRI™ CRT-D SureScan™
Version Model NumberDTMC1D1
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
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]
GS100763000060091 [Primary]

FDA Product Code

NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

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 [Compia MRI™ CRT-D SureScan™]

00643169929692CRTD DTMC1D1 COMPIA MRI US DF1
00643169837706CRTD DTMC1D1 COMPIA MRI US DF1
00643169705807CRTD DTMC1D1 COMPIA MRI US DF1
00643169720732CRTD DTMC1D4 COMPIA MRI CRTD US
00763000060091CRTD DTMC1D1 COMPIA MRI US DF1

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