EFH-30 119964

GUDID 04035479006211

BIOTRONIK SE & Co. KG

Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve Pacing/defibrillation lead suture sleeve
Primary Device ID04035479006211
NIH Device Record Key73cb08eb-4af5-4c90-85c7-d1f22672a877
Commercial Distribution StatusIn Commercial Distribution
Brand NameEFH-30
Version Model Number119964
Catalog Number119964
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count3
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
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

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
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
GS104035479006211 [Package]
Contains: 04035479144890
Package: case [10 Units]
In Commercial Distribution
GS104035479144890 [Primary]
GS104035479147051 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTBpermanent pacemaker Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-19
Device Publish Date2014-08-25

Devices Manufactured by BIOTRONIK SE & Co. KG

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04035479184285 - NEO2023-12-25
04035479184292 - PSW2023-12-25
04035479185510 - Renamic Neo NEOexpress2023-12-25
04035479183264 - Home Monitoring Service Center2023-10-23
04035479100650 - S 60-C2023-10-09
04035479011864 - S 75-A2023-10-06

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