Rivacor 5 DR-T 429563

GUDID 04035479156893

BIOTRONIK SE & Co. KG

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 ID04035479156893
NIH Device Record Keyd0ee1d12-dfaa-45f7-8099-ebd777ad06e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRivacor 5 DR-T
Version Model Number429563
Catalog Number429563
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479156893 [Primary]

FDA Product Code

MRMDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-28
Device Publish Date2019-03-18

Devices Manufactured by BIOTRONIK SE & Co. KG

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04035479183264 - Home Monitoring Service Center2023-10-23
04035479100650 - S 60-C2023-10-09
04035479011864 - S 75-A2023-10-06

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