FDA.reportPublic FDA data

Merlin.net

Primary DI
05414734510035
Brand
Merlin.net
Company
CARDIOMEMS, INC.
Model
MN6000
Catalog number
MN6000
Device description
HF Portal
Published
2016-05-02
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
LWPImplantable pulse generator, pacemaker (non-CRT)
MOMSystem, hemodynamic, implantable
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
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
MOMSystem, Hemodynamic, ImplantableUnknown3
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
05414734510035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734510035054147345100355414734510035

GMDN Terms#

Term, Definition table
TermDefinition
Transtelephonic implantable pacemaker analysis systemAn assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
086938409
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067047014CardioMEMS™CM1220CM12202026-03-13
05415067047021CardioMEMS™CM1250CM12502026-03-13
05415067047038CardioMEMS™CM1230CM12302026-03-13
05415067047045CardioMEMS™CM1210CM12102026-03-13
05415067048325CardioMEMS™CM1200CM12002026-03-13
05415067049612CardioMEMS™CM1260CM12602026-03-13
05415067054838CardioMEMS™CM1200-RCM1200-R2026-03-13
05414734509800CardioMEMS™CM1100CM11002015-08-06
05415067034724CardioMEMS™CM3100CM31002022-04-27
05414734509237CardioMEMS™CM2000CM20002014-10-29
05415067034731CardioMEMS™CM3150CM31502022-04-27
05415067034915CardioMEMS™CM3120CM31202022-04-27
05414734509220CardioMEMS™CM1060CM10602023-06-22
05414734509299CardioMEMS™CM3020CM30202023-06-21
05414734509398CardioMEMS™CM3040CM30402023-06-21
05415067029331CardioMEMS™CM3000CM30002017-06-02
05414734509565CardioMEMS™GuidewireCM20102015-07-15
15414734509562CardioMEMS™GuidewireCM20102015-07-15
05414734509169CardioMEMS™CM1000CM10002014-10-29
05414734509176CardioMEMS™CM1010CM10102014-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00802526628900LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-05-14
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
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
00850008997143myCordella Handheld Patient Reader AlloyEndotronix, Inc.MOM2025-10-13
00763000812058NAMEDTRONIC, INC.OSR2025-04-12
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NIK2024-11-13
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NKE2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
00763000842536NAMEDTRONIC, INC.OSR2023-11-11
00763000612665MyCareLink™MEDTRONIC, INC.OSR2023-05-13
00763000181185NAMEDTRONIC, INC.OSR2023-01-30
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
05415067040404NAST. JUDE MEDICAL, INC.NIK2023-01-09
05415067040404NAST. JUDE MEDICAL, INC.OSR2023-01-09
05415067040404NAST. JUDE MEDICAL, INC.NKE2023-01-09
00763000688400CareLink SmartSync™MEDTRONIC, INC.OSR2022-10-28
00763000688479NAMEDTRONIC, INC.OSR2022-10-28
00763000688479NAMEDTRONIC, INC.NKE2022-10-28
05415067031174Merlin™ST. JUDE MEDICAL, INC.NIK2022-08-29