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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Home Monitoring Service Center - 04035479186128

No Description
BIOTRONIK SE & Co. KG
3.60
Not in Commercial Distribution

  • 04035479186128 ()
488670

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479184636

No Description
BIOTRONIK SE & Co. KG
3.59
Not in Commercial Distribution

  • 04035479184636 ()
486092

  • Implantable cardiac device management application software

PatientApp 2.8 - 04035479184445

No Description
BIOTRONIK SE & Co. KG
484448
In Commercial Distribution

  • 04035479184445 ()
484448

  • Implantable cardiac device management application software

PatientApp - 04035479183271

No Description
BIOTRONIK SE & Co. KG
2.7
In Commercial Distribution

  • 04035479183271 ()
482213

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479183264

No Description
BIOTRONIK SE & Co. KG
3.58
Not in Commercial Distribution

  • 04035479183264 ()
482190

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479182045

No Description
BIOTRONIK SE & Co. KG
3.57
Not in Commercial Distribution

  • 04035479182045 ()
480113

  • Implantable cardiac device management application software

Patient App - 04035479180461

No Description
BIOTRONIK SE & Co. KG
2.5
In Commercial Distribution

  • 04035479180461 ()
469464

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479179779

No Description
BIOTRONIK SE & Co. KG
3.55
Not in Commercial Distribution

  • 04035479179779 ()
474019

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479177942

No Description
BIOTRONIK SE & Co. KG
3.54
Not in Commercial Distribution

  • 04035479177942 ()
472068

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479176587

No Description
BIOTRONIK SE & Co. KG
3.53
Not in Commercial Distribution

  • 04035479176587 ()
466610

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479176143

No Description
BIOTRONIK SE & Co. KG
3.50
Not in Commercial Distribution

  • 04035479176143 ()
459761

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479175559

No Description
BIOTRONIK SE & Co. KG
3.51
Not in Commercial Distribution

  • 04035479175559 ()
462086

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479169466

No Description
BIOTRONIK SE & Co. KG
3.49
Not in Commercial Distribution

  • 04035479169466 ()
455929

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479168773

No Description
BIOTRONIK SE & Co. KG
3.48
Not in Commercial Distribution

  • 04035479168773 ()
453795

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479167509

No Description
BIOTRONIK SE & Co. KG
3.47
Not in Commercial Distribution

  • 04035479167509 ()
451625

  • Implantable cardiac device management application software

AVEA - 10846446064872

KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software

AVEA - 10846446064865

KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software

Model 4 CT Calibration Phantom - B052PHCTM40

Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object

Puritan Bennett - 30884521252954

End Tidal CO2 Monitoring Option For 980 Series Ventilator
Covidien LP
10084332
In Commercial Distribution

  • 30884521252954 ()


  • Ventilator application software

LUX-Dx™ - 00802526625404

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-110
In Commercial Distribution

  • 00802526625404 ()
667256-110

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526623110

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526623103

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software

myLUX™ - 00802526621307

Patient Kit
BOSTON SCIENTIFIC CORPORATION
666385-100
In Commercial Distribution

  • 00802526621307 ()
666385-100

  • Implantable cardiac device management application software

LUX-Dx™ Clinic Assistant Mobile Device - 00802526621017

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-100
In Commercial Distribution

  • 00802526621017 ()
667256-100

  • Implantable cardiac device management application software

myLUX™ Mobile Device - 00802526621000

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667259-100
In Commercial Distribution

  • 00802526621000 ()
667259-100

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618215

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618208

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software

LUX-Dx™ Clinic Assistant app - 00802526607615

LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software

myLUX™ patient app - 00802526607608

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software

LUX-Dx™ Clinic Assistant Kit with mobile device - 00802526607370

LUX-Dx(TM) Clinic Assistant Kit with mobile device
BOSTON SCIENTIFIC CORPORATION
666256-100
In Commercial Distribution

  • 00802526607370 ()
666256-100

  • Implantable cardiac device management application software

myLUX™ Patient Kit with mobile device - 00802526607363

MyLUX(TM) Patient Kit with mobile device
BOSTON SCIENTIFIC CORPORATION
666259-100
In Commercial Distribution

  • 00802526607363 ()
666259-100

  • Implantable cardiac device management application software

iCodeConnect Software - 06948538362075

iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution

  • 06948538362075 ()


  • Ventilator application software

Device Command Library - 00763000378363

SW 2692 CARELINK DEVICE COMMAND LIBRARY
MEDTRONIC, INC.
2692
In Commercial Distribution

  • 00763000378363 ()


  • Implantable cardiac device management application software

Instrument Command Library - 00763000378356

SW 2691 CARELINK INST COMMAND LIBRARY
MEDTRONIC, INC.
2691
In Commercial Distribution

  • 00763000378356 ()


  • Implantable cardiac device management application software

TriageHF™ - 00763000351656

SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software

AccuRhythm™ AI - 00763000504533

SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution

  • 00763000504533 ()


  • Implantable cardiac device management application software

AccuRhythm™ AI - 00763000504526

SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution

  • 00763000504526 ()


  • Implantable cardiac device management application software

AccuRhythm™ AI - 00763000504519

SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) Application - 00763000754914

SW D00U024 CARELINK SS LINQ II ICM
MEDTRONIC, INC.
D00U024
In Commercial Distribution

  • 00763000754914 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ LINQ II™ Platform Application - 00763000891091

SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software
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