FDA.reportPublic FDA data

myMerlinPulse™

Primary DI
05415067032812
Brand
myMerlinPulse™
Company
ST. JUDE MEDICAL, INC.
Model
APP1004
Catalog number
APP1004
Device description
Mobile application compatible to Android operating system
Published
2021-01-07
Public version status
New
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
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067032812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067032812054150670328125415067032812

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac device management application softwareAn application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.

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
true
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
05414734500586NAST. JUDE MEDICAL, INC.LWS2025-05-07
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.LWS2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.LWS2024-11-04
00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
05415067049414Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049421Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049469Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049476Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
00763000369743Epsila EV™MEDTRONIC, INC.LWS2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
00763000369767Epsila EV™ MRI SureScan™MEDTRONIC, INC.LWS2023-11-02
00763000571528NAMEDTRONIC, INC.LWS2023-07-30
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWS2022-08-29
00802526615108EMBLEM™ S-ICD ProgrammerBOSTON SCIENTIFIC CORPORATIONLWS2022-01-26
00802526588280RESONATE™ HF ICD VRBOSTON SCIENTIFIC CORPORATIONLWS2021-07-12
00802526588310RESONATE™ HF ICD DRBOSTON SCIENTIFIC CORPORATIONLWS2021-07-12
00763000178338Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.LWS2020-11-22
00763000178345Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.LWS2020-11-22
00763000178451Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.LWS2020-11-22
00763000178468Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.LWS2020-11-22
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.LWS2020-11-13
00643169837751Evera MRI™ XT VR SureScan™MEDTRONIC, INC.LWS2020-11-13
00763000060060Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.LWS2020-09-04
05415067031990Gallant™ST. JUDE MEDICAL, INC.LWS2020-09-02
05415067032836Entrant™ST. JUDE MEDICAL, INC.LWS2020-09-02
00763000178390Cobalt™ DR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00763000178499Cobalt™ VR MRI SureScan™MEDTRONIC, INC.LWS2020-06-08
00802526611322ZOOM® LATITUDE®BOSTON SCIENTIFIC CORPORATIONLWS2019-11-07
00802526610516EMBLEM™ S-ICD ProgrammerBOSTON SCIENTIFIC CORPORATIONLWS2019-11-06
04035479156756Ilivia Neo 7 VR-T DXBIOTRONIK SE & Co. KGLWS2019-09-10