DH IS-1/DF4 401297

GUDID 04035479138516

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead
Primary Device ID04035479138516
NIH Device Record Key1b0f489c-d38b-4e4a-a856-425ada878dd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDH IS-1/DF4
Version Model Number401297
Catalog Number401297
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count2
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 Batchtrue
Serial Numberfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479138516 [Primary]
GS104035479158101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

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 Date2017-03-27

On-Brand Devices [DH IS-1/DF4]

04035479138523401298
04035479138516401297

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