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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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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

ICU Medical MedNet - 10887709101811

Mednet Software
ICU MEDICAL, INC.
6.32.0
In Commercial Distribution

  • 10887709101811 ()
160379203

  • Infusion pump medication-dosage application software

Vyaire - 04250892905709

SentrySuite Software
Jaeger Medical GmbH
3.10
In Commercial Distribution

  • 04250892905709 ()
V-770962-13

  • Pulmonary function analysis system, adult

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 - 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

EncoreBasic - 00606959039667

EncoreBasic Software
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959039667 ()
1068689

  • Medical equipment clinical data interfacing software

MAESTRO 11 - 09008737983307

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
98330
Not in Commercial Distribution

  • 09008737983307 ()


  • Audiometric/hearing device software
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