Linox 359065

GUDID 04035479100384

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 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 ID04035479100384
NIH Device Record Key9b7e722b-f7cd-41d5-8948-ea84bb7d00b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLinox
Version Model NumberSmart SD 60/16
Catalog Number359065
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 Producttrue
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

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479100384 [Primary]

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 Date2014-08-06

On-Brand Devices [Linox]

04035479116194Smart S 60
04035479112998Smart T 65
04035479112981Smart S 75
04035479112974Smart S 65
04035479110024Smart S DX 65/17
04035479110017Smart S DX 65/15
04035479100476Smart TD 65/18
04035479100469Smart TD 65/16
04035479100414Smart SD 75/18
04035479100407Smart SD 65/18
04035479100391Smart SD 65/16
04035479100384Smart SD 60/16

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