TriageHF™

GUDID 00763000351656

SOFTWARE 5242 TRIAGEHF US

MEDTRONIC, INC.

Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software
Primary Device ID00763000351656
NIH Device Record Keyc361a016-4f82-4ee1-896f-2949ecfa19c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriageHF™
Version Model Number5242
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 Batchtrue
Serial Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]
GS100763000351656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by MEDTRONIC, INC.

00763000416768 - NA2020-08-10 CUSTOM PACK BB6C91R12 SELLKE PK
20763000416786 - NA2020-08-10 CUSTOM PACK CB11J97R 20PK 1/4 LINE
00763000417420 - NA2020-08-10 CUSTOM PACK CB11J80R 10PK CENTRIMAG
00763000270988 - SimuPlus™2020-08-07 BAND 7700FB26 SIMUPLUS FLEX 26MM US
00763000270995 - SimuPlus™2020-08-07 BAND 7700FB28 SIMUPLUS FLEX 28MM US
00763000271008 - SimuPlus™2020-08-07 BAND 7700FB30 SIMUPLUS FLEX 30MM US
00763000271015 - SimuPlus™2020-08-07 BAND 7700FB32 SIMUPLUS FLEX 32MM US
00763000271022 - SimuPlus™2020-08-07 BAND 7700FB34 SIMUPLUS FLEX 34MM US

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.