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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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QuantaFlo - 00859433006123

Software Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph

Diopsys® - 00850514007091

NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system

Merlin.net™ - 05415067047311

Merlin.net Software
ST. JUDE MEDICAL, INC.
MN7000
In Commercial Distribution

  • 05415067047311 ()
MN7000

  • Transtelephonic implantable pacemaker analysis system

EnSite Precision™ - 05415067046802

Software Upgrade
ST. JUDE MEDICAL, INC.
H704002
In Commercial Distribution

  • 05415067046802 ()
H704002

  • Cardiac mapping system application software

EnSite Precision™ - 05415067046185

Software Upgrade
ST. JUDE MEDICAL, INC.
H704001
In Commercial Distribution

  • 05415067046185 ()
H704001

  • Cardiac mapping system application software

NA - 05415067040404

MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system

EnSite™ - 05415067038098

Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software

EnSite™ - 05415067037763

Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software

JointVue jFit - 00850014885021

jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software

Sunrise - 05430001896015

Sunrise software
Sunrise
1
In Commercial Distribution

  • 05430001896015 ()


  • Sleep disorder interpretive software, professional-only

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750382

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750375

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750368

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750214

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X5) - 05425025750191

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X50) - 05425025750184

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer

On Call Diabetes Management Software - 00682607001118

PC Software
ACON LABORATORIES, INC.
1.2.89
In Commercial Distribution

  • 00682607001118 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

Cadi - 00066714700155

Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 00066714700155 ()
CADI

  • Radiology information system application software

CRW® - 10381780252658

ATLASPLAN Software
INTEGRA LIFESCIENCES CORPORATION
ATLASSW
Not in Commercial Distribution

  • M248ATLASSW1 ()
  • 10381780252658 ()


  • Neurological stereotactic surgery system

SurgiCount - 07613327622799

+ QBL Software
STRYKER CORPORATION
0894000005
In Commercial Distribution

  • 07613327622799 ()
0894-000-005

  • Electronic surgical sponge-counter

Triton - 07613327622775

QBL Software
STRYKER CORPORATION
0894000002
In Commercial Distribution

  • 07613327622775 ()
0894-000-002

  • Blood weighing scale

Triton - 07613327622768

AI Software
STRYKER CORPORATION
0894000001
In Commercial Distribution

  • 07613327622768 ()
0894-000-001

  • Blood loss estimation application software

Scopis - 07613327513950

Planning Software
Stryker Leibinger GmbH & Co. KG
8000-021-005
In Commercial Distribution

  • 07613327513950 ()
8000-021-005

  • Stereotactic system application software

Scopis - 07613327513943

ENT Software
Stryker Leibinger GmbH & Co. KG
8000-021-001
In Commercial Distribution

  • 07613327513943 ()
8000-021-001

  • Stereotactic system application software

OPTIS™ - 00812059021925

Software Upgrade
LIGHTLAB IMAGING, INC.
Software Upgrade
In Commercial Distribution

  • 00812059021925 ()
E4-STD-WW

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021918

Software Upgrade
LIGHTLAB IMAGING, INC.
Metallic Stent Optimization Software
In Commercial Distribution

  • 00812059021918 ()
E4-FULL-WW

  • Coronary optical coherence tomography system

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

Vyaire - 04250892905945

SentrySuite Software
Jaeger Medical GmbH
3.30
In Commercial Distribution

  • 04250892905945 ()
V-770968

  • Pulmonary function analysis system, adult

Vyaire - 04250892905891

SentrySuite Software
Jaeger Medical GmbH
3.20
In Commercial Distribution

  • 04250892905891 ()
V-770965

  • Cardiopulmonary stress exercise monitoring system

Vyaire - 04250892905709

SentrySuite Software
Jaeger Medical GmbH
3.10
In Commercial Distribution

  • 04250892905709 ()
V-770962-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904634

SentrySuite Software
Jaeger Medical GmbH
2.15
In Commercial Distribution

  • 04250892904634 ()
V-770843-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904627

SentrySuite Software
Jaeger Medical GmbH
2.19
In Commercial Distribution

  • 04250892904627 ()
V-770845-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904610

SentrySuite Software
Jaeger Medical GmbH
2.21
In Commercial Distribution

  • 04250892904610 ()
V-770846

  • Pulmonary function analysis system, adult

Vyaire - 04250892904603

SentrySuite Software
Jaeger Medical GmbH
3.0
In Commercial Distribution

  • 04250892904603 ()
V-770847

  • Pulmonary function analysis system, adult

Vyaire - 04250892904597

JLAB Software
Jaeger Medical GmbH
5.7
In Commercial Distribution

  • 04250892904597 ()
V-770868-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904580

JLAB Software
Jaeger Medical GmbH
5.7
In Commercial Distribution

  • 04250892904580 ()
V-770808

  • Pulmonary function analysis system, adult

SentrySuite - 04250892901053

SentrySuite Software
Jaeger Medical GmbH
2.21
Not in Commercial Distribution

  • 04250892901053 ()
V-770846

  • Pulmonary function analysis system, adult

Jaeger - 04250892900667

SentrySuite Software
Jaeger Medical GmbH
2.19
Not in Commercial Distribution

  • 04250892900667 ()
V-770845-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900186

SentrySuite Software
Jaeger Medical GmbH
2.17
Not in Commercial Distribution

  • 04250892900186 ()
V-770844-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900179

SentrySuite Software
Jaeger Medical GmbH
2.15
Not in Commercial Distribution

  • 04250892900179 ()
V-770843-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900162

SentrySuite Software
Jaeger Medical GmbH
2.13
Not in Commercial Distribution

  • 04250892900162 ()
V-770842-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900100

JLAB Software
Jaeger Medical GmbH
5.7
Not in Commercial Distribution

  • 04250892900100 ()
V-770808

  • Pulmonary function analysis system, adult

Bionic Navigator™ 3D - 00191506007546

4.1 Software
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-410
In Commercial Distribution

  • 00191506007546 ()


  • Implantable electrical stimulation device management software

Arial - 00840948100840

Arial Software
Securitas Healthcare LLC
54302
In Commercial Distribution

  • 00840948100840 ()


  • Alarm application software

Vivo 50 - 07321820059287

PC Software
Breas Medical AB
005928
In Commercial Distribution

  • 07321820059287 ()
005928

  • Medical equipment clinical data interfacing software

Spirotrac - 65099169686801

68680 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 05099169706101 ()
  • 15099169676807 ()
  • 65099169686801 ()


  • Diagnostic spirometer, professional

Spirotrac - 65099169686795

68679 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 15099169676739 ()
  • 65099169686795 ()
  • 05099169706033 ()


  • Diagnostic spirometer, professional

Spirotrac - 65099169686757

68675 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 05099169706088 ()
  • 15099169676784 ()
  • 65099169686757 ()
  • 15099169676791 ()
  • 05099169706095 ()
  • 05099169706118 ()
  • 15099169676814 ()


  • Diagnostic spirometer, professional

Spirotrac - 65099169686740

68674 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 15099169676760 ()
  • 65099169686740 ()
  • 05099169706064 ()
  • 15099169676814 ()
  • 05099169706118 ()
  • 15099169676777 ()
  • 05099169706071 ()
  • 05099169706057 ()
  • 15099169676753 ()
  • 05099169706040 ()
  • 05099169706026 ()
  • 15099169676746 ()
  • 05099169706125 ()
  • 15099169676821 ()
  • 15099169676722 ()
  • 15099169676852 ()
  • 15099169676715 ()
  • 05099169706156 ()
  • 05099169706019 ()
  • 05099169706194 ()
  • 15099169676890 ()


  • Diagnostic spirometer, professional

NaviCare® Patient Safety Systems - 00887761985193

Medical Software
HILL-ROM, INC.
3.9
In Commercial Distribution

  • 00887761985193 ()


  • Bedside information system application software
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