Itrevia 5 DR-T 392422

GUDID 04035479128906

BIOTRONIK SE & Co. KG

Dual-chamber implantable defibrillator
Primary Device ID04035479128906
NIH Device Record Keyf8f787dc-8762-407b-88b7-e6ca9a6e1c7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameItrevia 5 DR-T
Version Model Number392422
Catalog Number392422
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
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 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
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
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
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
GS104035479128906 [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 Number4
Public Version Date2019-10-28
Device Publish Date2015-02-18

On-Brand Devices [Itrevia 5 DR-T]

04035479128906392422
04035479128852392417

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