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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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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

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 Express™ Mobile System - 00643169636668

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

  • 00643169636668 ()


  • 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

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 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 - 00643169731004

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

  • 00643169731004 ()


  • 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

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

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

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 - 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

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

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 - 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 - 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 - 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 - 04035479187163

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

  • 04035479187163 ()
490688

  • 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 - 04035479182045

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

  • 04035479182045 ()
480113

  • 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 - 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 - 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 - 04035479167509

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

  • 04035479167509 ()
451625

  • 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

Vista ® - 05020583252035

Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system

Vista® - 05020583252028

Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system

Vista ® - 05020583252011

Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


  • Blood bank information system

Trucise® 2.0 Total System - 05020583300088

Trucise 2.0 Communication Module
TERUMO BCT, INC.
METCM2
In Commercial Distribution

  • 05020583300088 ()


  • Blood bank information system

ACE - 00614950025497

CALCULATOR FOR X-RAY L/F MAGNIFICATION
ACE SURGICAL SUPPLY CO., INC.
0031967
In Commercial Distribution

  • 00614950025497 ()
0031967

  • Stationary panoramic dental x-ray system, analogue

PantOs 16 xp - E31584682012000

Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468201200
In Commercial Distribution

  • E31584682012000 ()


  • Stationary panoramic dental x-ray system, analogue

PantOs 16 xp Ceph - E31584682005000

Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200500
In Commercial Distribution

  • E31584682005000 ()


  • Stationary panoramic dental x-ray system, analogue

PantOs 16 xp - E31584682001000

Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200100
In Commercial Distribution

  • E31584682001000 ()


  • Stationary panoramic dental x-ray system, analogue
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