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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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Neurofax - 00841983103988

MEDICAL ISOLATION TRANSFORMER
NIHON KOHDEN AMERICA, INC.
A/ABC300-11MED
In Commercial Distribution

  • 00841983103988 ()
A/ABC300-11MED

  • Electroencephalograph

NEUROFAX - 00841983103971

NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

  • Electroencephalograph

NEUROFAX - 00841983103926

EEG REVIEW SUITE, 5 USER LICENSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-5
In Commercial Distribution

  • 00841983103926 ()
NK-REVSUITE-5

  • Electroencephalograph

NEUROFAX - 00841983103919

EEG REVIEW SUITE, 10 USER LICENSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-10
In Commercial Distribution

  • 00841983103919 ()
NK-REVSUITE-10

  • Electroencephalograph

NEUROFAX - 00841983103858

LIVE VIEW PANEL SYSTEM
NIHON KOHDEN AMERICA, INC.
A/LVP
In Commercial Distribution

  • 00841983103858 ()
A/LVP

  • Electroencephalograph

NEUROFAX - 00841983103841

EEG REVIEW SYSTEM
NIHON KOHDEN AMERICA, INC.
A/EEGR
In Commercial Distribution

  • 00841983103841 ()
A/EEGR

  • Electroencephalograph

NEUROFAX - 00841983103834

256 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983103834 ()
JE-120A-24

  • Neurophysiologic monitoring system

NEUROFAX - 00841983103827

192 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-23
In Commercial Distribution

  • 00841983103827 ()
JE-120A-23

  • Neurophysiologic monitoring system

NEUROFAX - 00841983103810

128 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-22
In Commercial Distribution

  • 00841983103810 ()
JE-120A-22

  • Neurophysiologic monitoring system

NEUROFAX - 00841983103797

NEUROFAX ACQUISITION, PANEL PC
NIHON KOHDEN AMERICA, INC.
EEG-1250A
In Commercial Distribution

  • 00841983103797 ()
EEG-1250A

  • Electroencephalograph

NA - 00841983103780

EEG-1200A RAID SYSTEM, WIN7
NIHON KOHDEN AMERICA, INC.
EEG-1200A-RAID
In Commercial Distribution

  • 00841983103780 ()
EEG-1200A-RAID

  • Electroencephalograph

NEUROFAX - 00841983103773

NEUROFAX ACQUISITION, SML FRM
NIHON KOHDEN AMERICA, INC.
EEG-1200AA
In Commercial Distribution

  • 00841983103773 ()
EEG-1200AA

  • Electroencephalograph

GCX - 00841983103766

CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/SONYCART-3
In Commercial Distribution

  • 00841983103766 ()
A/SONYCART-3

  • Instrument trolley

GCX - 00841983103759

CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/SONYCART
In Commercial Distribution

  • 00841983103759 ()
A/SONYCART

  • Instrument trolley

NA - 00841983103728

CABLE ASSEMBLY, PHOTIC, 3 FT
NIHON KOHDEN AMERICA, INC.
A/PHOTIC-3
In Commercial Distribution

  • 00841983103728 ()
A/PHOTIC-3

  • General-purpose multi-parameter bedside monitor

NA - 00841983103711

HL-7 NEUROWORKBENCH INTERFACE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7NIS
In Commercial Distribution

  • 00841983103711 ()
A/NWB-HL7NIS

  • Medical networking interface unit

MODO - 00841983103704

CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/NIH8000
In Commercial Distribution

  • 00841983103704 ()
A/NIH8000

  • Instrument trolley

GCX - 00841983103698

VHRS EEG CART WITHOUT CAMERA
NIHON KOHDEN AMERICA, INC.
A/GCXCART
In Commercial Distribution

  • 00841983103698 ()
A/GCXCART

  • Instrument trolley

NA - 00841983103681

DC INPUT BOX FOR JE-120A AMPLIFIER
NIHON KOHDEN AMERICA, INC.
A/DCIN1200
In Commercial Distribution

  • 00841983103681 ()
A/DCIN1200

  • Electroencephalograph

EEG Trend Program - 00841983103674

EEG TREND SOFTWARE REVIEW, 10 USER
NIHON KOHDEN AMERICA, INC.
QP-160R-10
In Commercial Distribution

  • 00841983103674 ()
QP-160R-10

  • Electroencephalograph

NEUROFAX - 00841983103650

EEG REVIEW SUITE, MULTIUSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-MU
In Commercial Distribution

  • 00841983103650 ()
NK-REVSUITE-MU

  • Electroencephalograph

NA - 00841983103643

PHOTIC ASSEMBLY WITH STIM CONTROL
NIHON KOHDEN AMERICA, INC.
NK-LS-901AJ
In Commercial Distribution

  • 00841983103643 ()
NK-LS-901AJ

  • Electroencephalograph

NA - 00841983103353

MINI JUNCTION BOX
NIHON KOHDEN AMERICA, INC.
JE-915A
In Commercial Distribution

  • 00841983103353 ()
JE-915A

  • Electroencephalograph

NA - 00841983102585

Input box converter, EEG-1200A
NIHON KOHDEN AMERICA, INC.
QI-122A
In Commercial Distribution

  • 00841983102585 ()
QI-122A

  • Electroencephalograph

NA - 00841983102486

Flat Pack Mini Expansion, Channel 193-256
NIHON KOHDEN AMERICA, INC.
JE-228AK
In Commercial Distribution

  • 00841983102486 ()
JE-228AK

  • Electroencephalograph

Neurofax - 00841983102417

Neurofax Electroencephalograph
NIHON KOHDEN AMERICA, INC.
EEG-1200A
In Commercial Distribution

  • 00841983102417 ()
EEG-1200A

  • Electroencephalograph

NA - 00841983101304

EEG trend program
NIHON KOHDEN AMERICA, INC.
QP-160AK
In Commercial Distribution

  • 00841983101304 ()
QP-160AK

  • Electroencephalograph

NA - 00841983101106

Analog output unit
NIHON KOHDEN AMERICA, INC.
QD-120A
In Commercial Distribution

  • 00841983101106 ()
QD-120A

  • Electroencephalograph

NA - 00841983100963

Photic stimulator control unit
NIHON KOHDEN AMERICA, INC.
LS-120AJ
In Commercial Distribution

  • 00841983100963 ()
LS-120AJ

  • Electroencephalograph

NA - 00841983100895

CART, COMPACT TYPE, EEG-1200A
NIHON KOHDEN AMERICA, INC.
KE-122A
In Commercial Distribution

  • 00841983100895 ()
KE-122A

  • Instrument trolley

NA - 00841983100284

ADAPTER DUAL MOUNT, PHOTIC / INPUT
NIHON KOHDEN AMERICA, INC.
DI-120A
In Commercial Distribution

  • 00841983100284 ()
DI-120A

  • Instrument trolley

Vigilant Software Suite - 04052682044106

Vigilant Master Med is a component of the Vigilant Software Suite. Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices.
Fresenius Kabi AG
ZK288122
In Commercial Distribution

  • 04052682044106 ()
ZK288122

  • Infusion pump medication-dosage application software

BD Intelliport - 00382905167508

MOUNT
BECTON, DICKINSON AND COMPANY
516750
In Commercial Distribution

  • 60382905167500 ()
  • 00382905167508 ()
516750

  • Intravenous injection automated detection/documentation system processor/transmitter

BD Intelliport - 00382905167065

KIT GATEWAY
BECTON, DICKINSON AND COMPANY
516706
In Commercial Distribution

  • 60382905167067 ()
  • 00382905167065 ()
516706

  • Anaesthesia information system application software

BD Intelliport - 00382905167041

KIT TABLET
BECTON, DICKINSON AND COMPANY
516704
In Commercial Distribution

  • 00382905167041 ()
516704

  • Intravenous injection automated detection/documentation system computer

Alaris - 10885403960123

Alaris Systems Manager v12-12.5.1
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403960123 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403897535

Alaris Systems Maintenance v12.3-v.12.5
CAREFUSION 303, INC.
8975
In Commercial Distribution

  • 10885403897535 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403897511

Alaris Systems Maintenance
CAREFUSION 303, INC.
8975
Not in Commercial Distribution

  • 10885403897511 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403896125

Alaris Guardrails Editor 12-12.1.3
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403896125 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403896118

Alaris Guardrails Editor 10.X
CAREFUSION 303, INC.
8961
Not in Commercial Distribution

  • 10885403896118 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403520020

Alaris Guardrails Editor 12.1.4
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403520020 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403519666

Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403519666 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403510489

Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software

NA - 10885403510472

Infusion Adapter (v1.7.X)
CAREFUSION 303, INC.
Infusion Adapter
In Commercial Distribution

  • 10885403510472 ()


  • Infusion pump medication-dosage application software

Orthex - 00841132179772

Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation system, single-use

Arcad Aligners - 00860011071921

Top and Bottom Aligners
ARCADLAB
Clear Orthodontic Aligners
In Commercial Distribution

  • 00860011071921 ()


  • Orthodontic aligner auxiliary attachment kit

TempoSmart - B553TEMPOSMART110

TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software

TempoSmart - B553TEMPOSMART100

TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOSMART100 ()


  • Home pharmaceutical management support software

Tempo Insights - B553TEMPOINSIGHTS110

Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software

Tempo Insights - B553TEMPOINSIGHTS100

Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
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