FDA.reportPublic FDA data

NA

Primary DI
05414734509138
Brand
NA
Company
ST. JUDE MEDICAL, INC.
Model
3630W
Catalog number
3630W
Device description
Merlin Wand
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734509138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734509138054147345091385414734509138

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-40 Degrees Celsius70 Degrees Celsius
Handling Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16
05415067031600Navitor™NVTR-29NVTR-292023-01-16
05415067010728Portico™PRT-23PRT-232021-09-20
05415067012487Portico™PRT-25PRT-252021-09-20
05415067012494Portico™PRT-27PRT-272021-09-20
05415067012500Portico™PRT-29PRT-292021-09-20
05415067031914Aveir™LSL02LSL022023-03-03
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479182809Acticor Sky HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182816Acticor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182854Rivacor Sky HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182861Rivacor Sky HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182984Rivacor Aura HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479182991Rivacor Aura HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183028Rivacor Rise HF-T QPBIOTRONIK SE & Co. KGNIK2026-04-20
04035479183035Rivacor Rise HF-TBIOTRONIK SE & Co. KGNIK2026-04-20
05414734506380NAST. JUDE MEDICAL, INC.NIK2025-12-22
05415067049575Merlin™ST. JUDE MEDICAL, INC.NIK2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NIK2024-11-13
05415067049513Entrant™ST. JUDE MEDICAL, INC.NIK2024-04-25
05415067049520Gallant™ST. JUDE MEDICAL, INC.NIK2024-04-25
05415067040404NAST. JUDE MEDICAL, INC.NIK2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.NIK2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.NIK2022-08-29
00802526589744RESONATE™ HF CRT-DBOSTON SCIENTIFIC CORPORATIONNIK2021-07-12
05415067032812myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
05415067032829myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
00763000178093Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178109Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178130Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178147Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
04035479140144Itrevia 5 HF-T QP DF4 IS4BIOTRONIK SE & Co. KGNIK2020-10-07