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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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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

Merlin™ - 05414734509725

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

  • 05414734509725 ()
3330

  • 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 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® Network - 00643169731004

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

  • 00643169731004 ()


  • 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

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

Merlin™ - 05415067049575

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

  • 05415067049575 ()
MLC1000

  • 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

CareLink® Network - 00643169480551

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

  • 00643169480551 ()


  • Implantable cardiac device management application software

e-Delphyn LIS Donor - 00860007282744

e-Delphyn LIS 21.x.x (US)
Gpi Usa, Inc.
21.x.x (US)
In Commercial Distribution

  • 00860007282744 ()


  • Blood bank information system

Surround 5.x - 00860007282737

Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system

ElDorado Donor 3.x.x - 00860007282713

ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Blood bank information system

e-Delphyn Donor - 00860007282706

e-Delphyn Donor version 11.x.x (US)
Gpi Usa, Inc.
11(US)
In Commercial Distribution

  • 00860007282706 ()


  • Blood bank information system

SW HMSC 3.63 - 04035479188689

No Description
BIOTRONIK SE & Co. KG
493223
In Commercial Distribution

  • 04035479188689 ()
493223

  • Implantable cardiac device management application software

SW HMSC 3.62 - 04035479187927

No Description
BIOTRONIK SE & Co. KG
491806
In Commercial Distribution

  • 04035479187927 ()
491806

  • Implantable cardiac device management application software

Home Monitoring Service Center - 04035479187163

No Description
BIOTRONIK SE & Co. KG
3.61
In Commercial Distribution

  • 04035479187163 ()
490688

  • Implantable cardiac device management application software

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
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