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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 - 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

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

Orthex External Fixation System - 00840194428002

Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software

Orthex - 00841132179772

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

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation frame calculation software

NA - 10841983103084

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

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

  • Electrocardiograph, professional, multichannel

Alaris - 10885403519666

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

  • 10885403519666 ()


  • Infusion pump medication-dosage application software
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