Epyra 8 HF-T 394918

GUDID 04035479131760

BIOTRONIK SE & Co. KG

Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker
Primary Device ID04035479131760
NIH Device Record Key3e47e60e-2cda-4a5b-9adc-efc0cd95bf4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpyra 8 HF-T
Version Model Number394918
Catalog Number394918
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

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
GS104035479131760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

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 Date2014-12-11

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