Plexa ProMRI DF-1 413998

GUDID 04035479150976

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead
Primary Device ID04035479150976
NIH Device Record Keydbfe7860-b666-4589-8463-61a97cac30f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlexa ProMRI DF-1
Version Model NumberS 75
Catalog Number413998
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479150976 [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 Number3
Public Version Date2021-02-05
Device Publish Date2018-03-01

On-Brand Devices [Plexa ProMRI DF-1]

04035479150983SD 60/16
04035479150952S 60
04035479150976S 75
04035479150969S 65

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