SW HMSC 3.62 491806

GUDID 04035479187927

BIOTRONIK SE & Co. KG

Implantable cardiac device management application software
Primary Device ID04035479187927
NIH Device Record Keye63a957d-aa6e-44f1-84c3-67a4c86b6292
Commercial Distribution StatusIn Commercial Distribution
Brand NameSW HMSC 3.62
Version Model Number491806
Catalog Number491806
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 Batchtrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479187927 [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 Date2025-01-28
Device Publish Date2025-01-20

Devices Manufactured by BIOTRONIK SE & Co. KG

04035479184445 - PatientApp 2.82025-02-20
04035479187927 - SW HMSC 3.622025-01-28
04035479187927 - SW HMSC 3.622025-01-28
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

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