FDA.reportPublic FDA data

Merlin™

Primary DI
05414734503143
Brand
Merlin™
Company
ST. JUDE MEDICAL, INC.
Model
EX3190
Catalog number
EX3190
Device description
RF Telemetry Antenna Adapter
Published
2014-09-30
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
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
05414734503143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734503143054147345031435414734503143

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker analyserAn electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.9Inch

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
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 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
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
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
05414734509138NAST. JUDE MEDICAL, INC.NIK2026-03-04
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