FDA.reportPublic FDA data

Merlin™

Primary DI
05415067031174
Brand
Merlin™
Company
ST. JUDE MEDICAL, INC.
Model
2
Catalog number
MER3700
Device description
Patient Care System (PCS)
Published
2022-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXYimplantable pacemaker Pulse-generator
LWOPulse-generator, single chamber, sensor driven, implantable
LWPImplantable pulse generator, pacemaker (non-CRT)
LWSImplantable cardioverter defibrillator (non-CRT)
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
LWOPulse-Generator, Single Chamber, Sensor Driven, ImplantableUnknown3
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3
NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Unknown3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067031174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067031174054150670311745415067031174

GMDN Terms#

Term, Definition table
TermDefinition
Multiple active implantable device programmerAn external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Handling Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067053039Current™PFA-AMP-RETURN-CBLPFA-AMP-RETURN-CBL2026-08-03
05415067055002Current™PFA-TSQ-CBLPFA-TSQ-CBL2026-08-03
05415067055583Current™PFA-GEN-OVERLAY-FPFA-GEN-OVERLAY-F2026-08-03
05415067055897Current™PFA-GEN-V110PFA-GEN-V1102026-08-03
00811806011295Amplatzer™9-PFO-0309-PFO-0302026-07-31
05415067045447Epic™EMAX-21EMAX-212023-08-01
05415067045454Epic™EMAX-25EMAX-252023-08-01
05415067045461Epic™EMAX-19EMAX-192023-08-01
05415067045478Epic™EMAX-23EMAX-232023-08-01
05415067033017Epic™E200-21AE200-21A2021-12-09
05415067033024Epic™E200-23AE200-23A2021-12-09
05415067033031Epic™E200-25AE200-25A2021-12-09
05415067033048Epic™E200-25ME200-25M2021-12-09
05415067033055Epic™E200-27AE200-27A2021-12-09
05415067033062Epic™E200-27ME200-27M2021-12-09
05415067033079Epic™E200-29AE200-29A2021-12-09
05415067033086Epic™E200-29ME200-29M2021-12-09
05415067033093Epic™E200-31ME200-31M2021-12-09
05415067033109Epic™E200-33ME200-33M2021-12-09
05415067033116Epic™ESP200-19ESP200-192021-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000862336MyCareLink™MEDTRONIC, INC.OSR2026-07-26
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KGOSR2024-12-18
04035479176143Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-20
04035479187163Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-03
04035479186005NEOBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-05-29
04035479184636Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-01-10
04035479184285NEOBIOTRONIK SE & Co. KGOSR2023-12-15
04035479184292PSWBIOTRONIK SE & Co. KGOSR2023-12-15
04035479185510Renamic Neo NEOexpressBIOTRONIK SE & Co. KGOSR2023-12-15
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-10-13
04035479182960NEOBIOTRONIK SE & Co. KGOSR2023-08-23
04035479182977PSWBIOTRONIK SE & Co. KGOSR2023-08-23
04035479179632PSWBIOTRONIK SE & Co. KGOSR2023-08-15
04035479179625NEOBIOTRONIK SE & Co. KGOSR2023-08-08
04035479174002Amvia Edge HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174033Amvia Sky HF-TBIOTRONIK SE & Co. KGNKE2023-07-12
04035479174040Amvia Sky HF-T QPBIOTRONIK SE & Co. KGNKE2023-07-12
04035479182045Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-05-11
04035479181536NEOBIOTRONIK SE & Co. KGOSR2023-04-19
04035479181543PSWBIOTRONIK SE & Co. KGOSR2023-04-19
04035479179687NEOBIOTRONIK SE & Co. KGOSR2023-01-16
04035479179694PSWBIOTRONIK SE & Co. KGOSR2023-01-16
04035479179779Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2022-10-24