FDA.reportPublic FDA data

Merlin.net™

Primary DI
05415067053275
Brand
Merlin.net™
Company
ST. JUDE MEDICAL, INC.
Model
MN7000
Catalog number
MN7000
Device description
Merlin.net Virtual Device Engine
Published
2025-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067053275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067053275054150670532755415067053275

GMDN Terms#

Term, Definition table
TermDefinition
Transtelephonic implantable pacemaker analysis systemAn assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055095Assert-IQ™ST. JUDE MEDICAL, INC.MXD2026-01-05
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
04035479169862BioMonitor IIImBIOTRONIK SE & Co. KGMXD2020-05-06