FDA.reportPublic FDA data

myMerlin™

Primary DI
05415067027399
Brand
myMerlin™
Company
ST. JUDE MEDICAL, INC.
Model
APP1000
Catalog number
APP1000
Device description
Mobile Application
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSIDETECTOR AND ALARM, ARRHYTHMIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067027399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067027399054150670273995415067027399

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac monitor programmer/transmitter/alarmA hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. It may be used in the home or healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838119130Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119233Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119240Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
05903021560223PocketECG IV - Unified Arrhythmia Diagnostic SystemMEDICALGORITHMICS S ADSI2025-12-04
B690MA20MoMe® ARCInfobionic, Inc.DSI2025-08-25
00852132007453BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2025-06-11
00852132007491BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2025-06-11
00857769008088Life Sensing Instruments, Inc.LIFE SENSING INSTRUMENTS, INC.DSI2025-04-01
00884838114685NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-24
00884838114708NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-24
00884838114654NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-23
00884838114661NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-23
00884838114678NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-23
00884838114692NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-23
00884838114715NIBP CuffsPhilips Medizin Systeme Böblingen GmbHDSI2025-03-23
00852132007392BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2024-12-05
00852132007408BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2024-12-05
00852132007415BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2024-12-05
00852132007422BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2024-12-05
00852132007439BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2024-12-05
00852132007446BodyGuardian KitPREVENTICE TECHNOLOGIES, INC.DSI2024-12-05
B146C6R30C6 Sensor 3.0, RebuiltBRAEMAR MANUFACTURING, LLCDSI2024-06-26
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCDSI2024-06-07
10841522124662TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2024-06-07
10841522124679TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2024-06-07
10841522124686TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2024-06-07
10841522124693TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2024-06-07
10841522124716TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2024-06-07
00857769008057Life Sensing Instruments, Inc.LIFE SENSING INSTRUMENTS, INC.DSI2024-03-19
00857769008064Life Sensing Instruments, Inc.LIFE SENSING INSTRUMENTS, INC.DSI2024-03-19