Eluna 8 DR 394970

GUDID 04035479131944

BIOTRONIK SE & Co. KG

Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive
Primary Device ID04035479131944
NIH Device Record Key39c9668a-d33c-4cb7-a71d-e6c6547c3c75
Commercial Distribution StatusIn Commercial Distribution
Brand NameEluna 8 DR
Version Model Number394970
Catalog Number394970
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
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 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479131944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2014-12-09

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