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

  • 00841983103926 ()
NK-REVSUITE-5

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

  • 00841983103919 ()
NK-REVSUITE-10

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

  • 00841983103858 ()
A/LVP

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

  • 00841983103841 ()
A/EEGR

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

  • 00841983103834 ()
JE-120A-24

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

  • 00841983103827 ()
JE-120A-23

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

  • 00841983103810 ()
JE-120A-22

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

  • 00841983103797 ()
EEG-1250A

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

  • 00841983103780 ()
EEG-1200A-RAID

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

  • 00841983103773 ()
EEG-1200AA

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

  • 00841983103766 ()
A/SONYCART-3

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

  • 00841983103759 ()
A/SONYCART

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

  • 00841983103711 ()
A/NWB-HL7NIS

  • Medical networking interface unit
CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/NIH8000
In Commercial Distribution

  • 00841983103704 ()
A/NIH8000

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

  • 00841983103698 ()
A/GCXCART

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

  • 00841983103681 ()
A/DCIN1200

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

  • 00841983103674 ()
QP-160R-10

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

  • 00841983103650 ()
NK-REVSUITE-MU

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

  • 00841983103643 ()
NK-LS-901AJ

  • Electroencephalograph
NEUROFAX ACQUISITION, SML FRM
NIHON KOHDEN AMERICA, INC.
EEG-1260A
In Commercial Distribution

  • 00841983104329 ()
EEG-1260A

  • Electroencephalograph
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
Hearing Aid Feature watchOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095074 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149931 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation frame calculation software
Electrode Clip, Limb
NIHON KOHDEN AMERICA, INC.
NC-143E
In Commercial Distribution

  • 10841983103084 ()
  • 00841983103087 ()
NC-143E

  • Electrocardiograph, professional, multichannel
Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software
Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403519666 ()


  • Infusion pump medication-dosage application software
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