Home Monitoring Service Center 453795

GUDID 04035479168773

BIOTRONIK SE & Co. KG

Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software Implantable cardiac device management application software
Primary Device ID04035479168773
NIH Device Record Key9caa1926-a927-4278-a0c4-cf64a5283499
Commercial Distribution StatusIn Commercial Distribution
Brand NameHome Monitoring Service Center
Version Model Number3.48
Catalog Number453795
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479168773 [Primary]
GS104035479168773 [Primary]
GS104035479168773 [Primary]
GS104035479168773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components
OSRPacemaker/icd/crt non-implanted components
OSRPacemaker/icd/crt non-implanted components
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 Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Home Monitoring Service Center]

040354791617503.43
040354791661063.44
040354791664033.45
040354791674933.46
040354791675093.47
040354791687733.48

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