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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

NEUROFAX - 00841983103773

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

  • 00841983103773 ()
EEG-1200AA

  • Electroencephalograph

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

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

NA - 00841983102585

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

  • 00841983102585 ()
QI-122A

  • 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 - 00841983100284

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

  • 00841983100284 ()
DI-120A

  • Instrument trolley

Hearing Aid Feature (HAF) - 00195950095067

Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear

NA - 10841983103084

Electrode Clip, Limb
NIHON KOHDEN AMERICA, INC.
NC-143E
In Commercial Distribution

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

  • Electrocardiograph, professional, multichannel

Hearing Aid Feature (HAF) - 00195950095074

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 (HAF) - 00195949149931

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 (HAF) - 00195949149924

Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear

ABBOTT PRISM - 00380740138400

ABBOTT PRISM Director Version 2.1
ABBOTT LABORATORIES
3R97-02
Not in Commercial Distribution

  • 00380740138400 ()
03R9702

  • Laboratory instrument/analyser application software IVD

ABBOTT PRISM - 00380740138394

ABBOTT PRISM Director Version 2.0
ABBOTT LABORATORIES
3R97-01
Not in Commercial Distribution

  • 00380740138394 ()
03R9701

  • Laboratory instrument/analyser application software IVD

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

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

NA - 04931921112946

Photic stimulator control unit
NIHON KOHDEN CORPORATION
LS-120AJ
In Commercial Distribution

  • 04931921112946 ()
LS-120AJ

  • Electroencephalograph

NA - 04931921112885

CART, COMPACT TYPE, EEG-1200A
NIHON KOHDEN CORPORATION
KE-122A
In Commercial Distribution

  • 04931921112885 ()
KE-122A

  • Instrument trolley

NA - 04931921112724

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

  • 04931921112724 ()
DI-120A

  • Instrument trolley

Neurofax - 04931921110904

Neurofax Electroencephalograph
NIHON KOHDEN CORPORATION
EEG-1200A
In Commercial Distribution

  • 04931921110904 ()
EEG-1200A

  • Electroencephalograph

NA - 04931921108154

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

  • 04931921108154 ()
JE-228AK

  • Electroencephalograph

NA - 04931921107485

Analog output unit
NIHON KOHDEN CORPORATION
QD-120A
In Commercial Distribution

  • 04931921107485 ()
QD-120A

  • Electroencephalograph

NA - 04931921104170

Input box converter, EEG-1200A
NIHON KOHDEN CORPORATION
QI-122A
In Commercial Distribution

  • 04931921104170 ()
QI-122A

  • Electroencephalograph

Neurofax - 04931921009161

Neurofax Electroencephalograph
NIHON KOHDEN CORPORATION
EEG-1260A
In Commercial Distribution

  • 04931921009161 ()
EEG-1260A

  • Electroencephalograph

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007730

Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KE-122A-01
In Commercial Distribution

  • 04931921007730 ()
KE-122A-01

  • Instrument trolley

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007723

Cart, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KD-029A-01
In Commercial Distribution

  • 04931921007723 ()
KD-029A-01

  • Instrument trolley

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007716

Flash lamp assembly, Round shape
NIHON KOHDEN CORPORATION
LS-706A-01
In Commercial Distribution

  • 04931921007716 ()
LS-706A-01

  • Electroencephalograph

NA - 04931921004357

Bundled cable for JE-120A-256
NIHON KOHDEN CORPORATION
AAA-17041
In Commercial Distribution

  • 04931921004357 ()


  • Electroencephalograph

Q21 - 00860410000379

The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
NEUROFIELD, INC.
169
In Commercial Distribution

  • 00860410000379 ()


  • Multiple physiological signal amplifier

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
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