Iperia 7 DR-T 392423

GUDID 04035479128913

BIOTRONIK SE & Co. KG

Dual-chamber implantable defibrillator
Primary Device ID04035479128913
NIH Device Record Keyc083cc2e-1b6a-43ba-bfc4-59d304f9f405
Commercial Distribution StatusIn Commercial Distribution
Brand NameIperia 7 DR-T
Version Model Number392423
Catalog Number392423
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479128913 [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 Date2016-01-07

On-Brand Devices [Iperia 7 DR-T]

04035479128920392424
04035479128913392423
04035479128784392410
04035479128777392409

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