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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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g.Nautilus PRO - EBCI5110PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel
In Commercial Distribution

  • EBCI5110PRO0 ()

  • Channel Number 16
5110PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5101PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel-CSP
In Commercial Distribution

  • EBCI5101PRO0 ()

  • Channel Number 32
5101PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5100PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel
In Commercial Distribution

  • EBCI5100PRO0 ()

  • Channel Number 32
5100PRO

  • Multiple physiological signal amplifier

AVEA™ - 10190752175921

AVEA NIMV+VG SW KEY
VYAIRE MEDICAL, INC.
63865
In Commercial Distribution

  • 10190752175921 ()
63865

  • Ventilator application software

CareLink Express™ Mobile System - 00643169636668

SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software

Reveal LINQ™ Mobile Manager - 00643169636651

SW MSW002 LINQ PROGRAMMER iOS APP
MEDTRONIC, INC.
MSW002
In Commercial Distribution

  • 00643169636651 ()


  • Implantable cardiac device management application software

CareLink Express™ Mobile System - 00643169545526

SW 31301 CARELINK EXPRESS MOBILE USA
MEDTRONIC, INC.
31301
In Commercial Distribution

  • 00643169545526 ()


  • Implantable cardiac device management application software

Reveal LINQ™ Mobile Manager - 00643169545519

SW MSW001 LINQ MOBILE MANAGER USA
MEDTRONIC, INC.
MSW001
In Commercial Distribution

  • 00643169545519 ()


  • Implantable cardiac device management application software

CareLink® Network - 00643169480551

SW CLN03 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN03
Not in Commercial Distribution

  • 00643169480551 ()


  • Implantable cardiac device management application software

Guardian Programmer Model PROG-004 - 00850012625162

PROG-004 Kit (US)
Avertix Medical Inc.
0217-2100-004#P18
In Commercial Distribution

  • 00850012625162 ()
0217-2100-004#P18

  • Implantable cardiac device management application software

AngelMed Guardian Programmer PROG-003 Carrying Case - 00850012625148

PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution

  • 00850012625148 ()
0204-2100-079#P10

  • Implantable cardiac device management application software

AngelMed Guardian Programmer Application User's Manual CD - 00850012625131

PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution

  • 00850012625131 ()
0204-2100-073#P16

  • Implantable cardiac device management application software

AngelMed Guardian Programmer USB Flash Drive - 00850012625124

PROG-003 USB Flash Drive
Avertix Medical Inc.
0204-2100-077#P10
In Commercial Distribution

  • 00850012625124 ()
0204-2100-077#P10

  • Implantable cardiac device management application software

AngelMed Guardian Programmer External Power Accessories - 00850012625100

PROG-003 External Power Accessories Kit (US)
Avertix Medical Inc.
0204-2100-093#P10
In Commercial Distribution

  • 00850012625100 ()
0204-2100-093#P10

  • Implantable cardiac device management application software

AngelMed Guardian Programmer Serial Cable, 10 Foot - 00850012625094

PROG-003 Serial Cable (10 foot)
Avertix Medical Inc.
0204-2100-112
In Commercial Distribution

  • 00850012625094 ()
0204-2100-112

  • Implantable cardiac device management application software

AngelMed Guardian Programmer Serial Cable, 6 Foot - 00850012625087

PROG-003 Serial Cable (6 foot)
Avertix Medical Inc.
0204-2100-085#P10
In Commercial Distribution

  • 00850012625087 ()
0204-2100-085#P10

  • Implantable cardiac device management application software

AngelMed Guardian Programmer Model PROG-003 - 00850012625063

PROG-003 Kit (US)
Avertix Medical Inc.
0204-2100-075#P16
In Commercial Distribution

  • 00850012625063 ()
0204-2100-075#P16

  • Implantable cardiac device management application software

CareLink® Network - 00643169878075

SW CLN10 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN10
Not in Commercial Distribution

  • 00643169878075 ()


  • Implantable cardiac device management application software

CareLink® Network - 00643169878068

SW CLN09 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN09
Not in Commercial Distribution

  • 00643169878068 ()


  • Implantable cardiac device management application software

CareLink® Network - 00643169731004

SW CLN07 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN07
Not in Commercial Distribution

  • 00643169731004 ()


  • Implantable cardiac device management application software

myMerlinPulse™ - 05415067032829

Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software

myMerlinPulse™ - 05415067032812

Mobile application compatible to Android operating system
ST. JUDE MEDICAL, INC.
APP1004
In Commercial Distribution

  • 05415067032812 ()
APP1004

  • Implantable cardiac device management application software

Merlin™ - 05415067037121

2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software

Merlin™ - 05415067049575

Live Connect Remote Session Engine
ST. JUDE MEDICAL, INC.
MLC1000
In Commercial Distribution

  • 05415067049575 ()
MLC1000

  • Implantable cardiac device management application software

Merlin™ - 05414734509725

PCS 3330 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
3330
In Commercial Distribution

  • 05414734509725 ()
3330

  • Implantable cardiac device management application software

CareLink SmartSync™ PSA Application - 00643169833753

SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ Common Application - 00643169833739

SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ Common Application - 00643169833715

SW M01G02 CARELINK SMARTSYNC ANDROID
MEDTRONIC, INC.
M01G02
In Commercial Distribution

  • 00643169833715 ()


  • Implantable cardiac device management application software

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

ResScan - 00619498313365

ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software

ResScan - 00619498313358

RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software

ResScan - 00619498313341

RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution

  • 00619498313341 ()
31334

  • Ventilator application software

ResScan - 00619498313334

RESSCAN V6.0 CD ASSY
RESMED PTY LTD
31333
In Commercial Distribution

  • 00619498313334 ()
31333

  • Ventilator application software

ResScan - 00619498313327

RESSCAN V 5.9 CD ASSY
RESMED PTY LTD
31332
In Commercial Distribution

  • 00619498313327 ()
31332

  • Ventilator application software

ResScan - 00619498313303

RESSCAN V 5.8 CD ASSY
RESMED PTY LTD
31330
In Commercial Distribution

  • 00619498313303 ()
31330

  • Ventilator application software

ResScan - 00619498313297

RESSCAN V 5.7 CD ASSY
RESMED PTY LTD
31329
In Commercial Distribution

  • 00619498313297 ()
31329

  • Ventilator application software

RESSCAN - 00619498313273

RESSCAN V 5.5 CD ASSY
RESMED PTY LTD
31327
In Commercial Distribution

  • 00619498313273 ()
31327

  • Ventilator application software

ResScan - 00619498313020

Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498313020 ()
31302

  • Ventilator application software

EasyCare Tx - 00619498259458

EasyCare Tx V9.0 CD ASSY
RESMED PTY LTD
25945
In Commercial Distribution

  • 00619498259458 ()
25945

  • Ventilator application software

EasyCare Tx - 00619498259441

EasyCare Tx CD ASSY
RESMED PTY LTD
25944
In Commercial Distribution

  • 00619498259441 ()
25944

  • Ventilator application software

AirView - 00619498000845

AirView
RESMED PTY LTD
4.2
In Commercial Distribution

  • 00619498000845 ()


  • Ventilator application software

RESSCAN - 00619498229154

RESSCAN DATA CARD MODULE
RESMED PTY LTD
22915
In Commercial Distribution

  • 00619498229154 ()
22915

  • Ventilator application software

AirMini app - 00619498222445

Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software

AirMini app - 00619498222438

iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software

AIRVIEW - 00619498222407

AIRVIEW
RESMED PTY LTD
22240
In Commercial Distribution

  • 00619498222407 ()
22240

  • Ventilator application software

RESSCAN - 00619498222070

RESSCAN DATA CARD READER
RESMED PTY LTD
22207
In Commercial Distribution

  • 00619498222070 ()
22207

  • Ventilator application software

RESSCAN - 00619498222032

RESSCAN USB ADAPTER
RESMED PTY LTD
22203
In Commercial Distribution

  • 00619498222032 ()
22203

  • Ventilator application software

ResScan - 00619498000722

Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • Ventilator application software

ResScan - 08401934313396

ResScan V7.0.2
RESMED CORP.
31339
In Commercial Distribution

  • 08401934313396 ()


  • Ventilator application software

ResScan - 08401934313389

ResScan v7.0.1
RESMED CORP.
31338
In Commercial Distribution

  • 08401934313389 ()


  • Ventilator application software
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