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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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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

NASOMETER - 04961333247301

NASOMETER SOFTWARE
PENTAX OF AMERICA, INC.
6500
In Commercial Distribution

  • 04961333247301 ()


  • Speech assistive training device

VISI-PITCH - 04961333236572

VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device

N/A - 04961333229987

Games, Software
PENTAX OF AMERICA, INC.
5167B
In Commercial Distribution

  • 04961333229987 ()


  • Electroglottograph

SONA-MATCH - 04961333229772

Sona-Match, Software
PENTAX OF AMERICA, INC.
5127
In Commercial Distribution

  • 04961333229772 ()


  • Electroglottograph

MULTI-SPEECH - 04961333229642

Multi-Speech Software
PENTAX OF AMERICA, INC.
3700
In Commercial Distribution

  • 04961333229642 ()


  • Electroglottograph

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

MedNet - 10887787001751

Metnet Software
HOSPIRA, INC.
6.20.01
In Commercial Distribution

  • 10887787001751 ()
160376404

  • Infusion pump medication-dosage application software

ICU Medical MedNet - 10887787009139

Mednet Software
ICU MEDICAL, INC.
6.31.01
In Commercial Distribution

  • 10887787009139 ()
160379202

  • Infusion pump medication-dosage application software

ICU Medical MedNet - 10887787009115

Mednet Software
ICU MEDICAL FLEET SERVICES, LLC
6.30.01
In Commercial Distribution

  • 10887787009115 ()
160379201

  • Infusion pump medication-dosage application software

Mammotome - 00841911101833

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
SCMSW6
In Commercial Distribution

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

Mammotome - 00841911100638

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
Version 6.2
In Commercial Distribution

  • 00841911100638 ()


  • Mammographic stereotactic biopsy system

ICU Medical MedNet - 10887709101811

Mednet Software
ICU MEDICAL, INC.
6.32.0
In Commercial Distribution

  • 10887709101811 ()
160379203

  • Infusion pump medication-dosage application software

NaviCare® WatchChild® Systems - 00887761001572

Medical Software
HILL-ROM, INC.
1.6
In Commercial Distribution

  • 00887761001572 ()


  • Obstetrics information system application software

NaviCare® SmartSync Systems - 00887761001565

Medical Software
HILL-ROM, INC.
3.6
In Commercial Distribution

  • 00887761001565 ()


  • Bedside information system application software

NaviCare® Patient Safety Systems - 00887761001558

Medical Software
HILL-ROM, INC.
3.6
In Commercial Distribution

  • 00887761001558 ()


  • Bedside information system application software

Vivo 50 - 07321820059287

PC Software
Breas Medical AB
005928
In Commercial Distribution

  • 07321820059287 ()
005928

  • Medical equipment clinical data interfacing software

OrthoNext™ Platform System Software - 18053340345675

ORTHONEXT SOFTWARE
ORTHOFIX SRL
2.0
In Commercial Distribution

  • 18053340345675 ()
ORTHONEXTSW

  • Radiological PACS software

Voalte SmartSync - 00887761995093

Medical Software
HILL-ROM, INC.
4.0
In Commercial Distribution

  • 00887761995093 ()


  • Bedside information system application software

Voalte Patient Safety - 00887761995086

Medical Software
HILL-ROM, INC.
4.0
In Commercial Distribution

  • 00887761995086 ()


  • Bedside information system application software

NaviCare® Patient Safety Systems - 00887761985193

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

  • 00887761985193 ()


  • Bedside information system application software

NaviCare® SmartSync Systems - 00887761985186

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

  • 00887761985186 ()


  • Bedside information system application software

DataTrak - 00886368000841

DataTrak Software
Thermogenesis Corp.
150040
In Commercial Distribution

  • 00886368000841 ()


  • Blood centrifugation system containment kit
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