Protego DF-1 414015

GUDID 04035479151058

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead
Primary Device ID04035479151058
NIH Device Record Key14ea1844-683d-4aa4-a0a2-1c8b273cd722
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtego DF-1
Version Model NumberSD 65/16
Catalog Number414015
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
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479151058 [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 Date2015-12-03

On-Brand Devices [Protego DF-1]

04035479151164T 65
04035479151157TD 75/18
04035479151140TD 65/18
04035479151133TD 65/16
04035479151126S DX 65/17
04035479151119S DX 65/15
04035479151102S 75
04035479151096S 65
04035479151089S 60
04035479151072SD 75/18
04035479151065SD 65/18
04035479151058SD 65/16
04035479151041SD 60/16

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