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
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
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
04035479186005NEOBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-05-29
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
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
00763000181185NAMEDTRONIC, INC.OSR2023-01-30