BIOMONITOR 436066

GUDID 04035479158453

BIOTRONIK SE & Co. KG

Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor
Primary Device ID04035479158453
NIH Device Record Key41606cbe-0d60-4273-8bb4-ad9446bd7fe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMONITOR
Version Model NumberIII
Catalog Number436066
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 Productfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479158453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXDRECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-07
Device Publish Date2019-07-10

On-Brand Devices [BIOMONITOR]

04035479158453III
040354791355392-S
040354791355222-AF
04035479131210394119
04035479144227Remote Assistant
04035479169862IIIm
04035479149314FIT-Fast Insert Tool 1 + 2, Set

Trademark Results [BIOMONITOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOMONITOR
BIOMONITOR
86538311 5046341 Live/Registered
BIOTRONIK SE & Co. KG
2015-02-18
BIOMONITOR
BIOMONITOR
79053841 3746900 Dead/Cancelled
BIOTRONIK SE & Co. KG
2008-01-30
BIOMONITOR
BIOMONITOR
79047745 3647657 Dead/Cancelled
BIOTRONIK SE & Co. KG
2007-11-01
BIOMONITOR
BIOMONITOR
78214992 2940748 Dead/Cancelled
Applera Corporation
2003-02-14
BIOMONITOR
BIOMONITOR
73014956 1016744 Dead/Expired
BIOCONTROL COMPANY
1974-03-04

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