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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 - 00841983103797

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

  • 00841983103797 ()
EEG-1250A

  • Electroencephalograph

NA - 00841983103681

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

  • 00841983103681 ()
A/DCIN1200

  • 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

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 - 00841983100963

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

  • 00841983100963 ()
LS-120AJ

  • Electroencephalograph

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

NA - 04931921871355

Electrode Clip, Limb, 4/BX
NIHON KOHDEN CORPORATION
NC-143E
In Commercial Distribution

  • 04931921871355 ()
NC-143E

  • Electrocardiograph, professional, multichannel

NA - 04931921112991

EEG trend program
NIHON KOHDEN CORPORATION
QP-160AK
In Commercial Distribution

  • 04931921112991 ()
QP-160AK

  • Electroencephalograph
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