Rivacor 7 VR-T 429536

GUDID 04035479156817

BIOTRONIK SE & Co. KG

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 ID04035479156817
NIH Device Record Keyd2fde28b-ef66-493a-9580-0e071e6a9a6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRivacor 7 VR-T
Version Model Number429536
Catalog Number429536
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
GS104035479156817 [Primary]

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

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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