FDA.reportPublic FDA data

BioMonitor

Primary DI
04035479135539
Brand
BioMonitor
Company
BIOTRONIK SE & Co. KG
Model
2-S
Catalog number
398494
Published
2016-04-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MXDRECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152995000BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.2016-04-11MXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479135539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479135539040354791355394035479135539

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac monitorA hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479194192PatientApp 2.10.05319975319972026-07-16
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055095Assert-IQ™ST. JUDE MEDICAL, INC.MXD2026-01-05
05415067053275Merlin.net™ST. JUDE MEDICAL, INC.MXD2025-10-21
00802526618208myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2025-04-11
00802526618215myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2025-04-11
00802526625404LUX-Dx™BOSTON SCIENTIFIC CORPORATIONMXD2024-09-30
00763000754914CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) ApplicationMEDTRONIC, INC.MXD2024-04-25
00763000891091CareLink SmartSync™ LINQ II™ Platform ApplicationMEDTRONIC, INC.MXD2024-04-25
00802526621017LUX-Dx™ Clinic Assistant Mobile DeviceBOSTON SCIENTIFIC CORPORATIONMXD2023-12-14
00763000613747LINQ II™MEDTRONIC, INC.MXD2023-11-19
00802526621000myLUX™ Mobile DeviceBOSTON SCIENTIFIC CORPORATIONMXD2023-09-08
00802526620706LUX-Dx II+™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526620713LUX-Dx II™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526621307myLUX™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526623103myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526623110myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
04035479177850BioMonitor IVBIOTRONIK SE & Co. KGMXD2023-05-24
00763000504519AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000504526AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000504533AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000562625Reveal LINQ™MEDTRONIC, INC.MXD2021-09-04
00763000562632Reveal LINQ™MEDTRONIC, INC.MXD2021-09-04
00763000554002LINQ II™MEDTRONIC, INC.MXD2021-06-14
00763000060374LINQ II™MEDTRONIC, INC.MXD2020-07-18
00763000162191LINQ II™MEDTRONIC, INC.MXD2020-07-18
00802526607103LUX-Dx™ Insertable Cardiac MonitorBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607363myLUX™ Patient Kit with mobile deviceBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607370LUX-Dx™ Clinic Assistant Kit with mobile deviceBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607608myLUX™ patient appBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607615LUX-Dx™ Clinic Assistant appBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526613838LATITUDE® ClarityBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01