NEO 2401.U/1 492817

GUDID 04035479188399

BIOTRONIK SE & Co. KG

Cardiac pulse generator programmer
Primary Device ID04035479188399
NIH Device Record Key1056b3b0-c736-402f-84fc-cf0db61fee8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEO 2401.U/1
Version Model Number492817
Catalog Number492817
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 Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479188399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-26
Device Publish Date2024-12-18

Devices Manufactured by BIOTRONIK SE & Co. KG

04035479188399 - NEO 2401.U/12024-12-26
04035479188399 - NEO 2401.U/12024-12-26
04035479001575 - M-502024-10-24
04035479176143 - Home Monitoring Service Center2024-09-30
04035479184636 - Home Monitoring Service Center2024-09-23
04035479187163 - Home Monitoring Service Center2024-09-11
04035479186005 - NEO2024-06-25
04035479186012 - PSW2024-06-25
04035479052515 - PK-222 US/2,8m2024-06-06

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