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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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NA - 00841983102592

BASE UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-123A
In Commercial Distribution

  • 00841983102592 ()
QI-123A

  • Electroencephalograph

NA - 00841983101199

EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-124A
In Commercial Distribution

  • 00841983101199 ()
QI-124A

  • Electroencephalograph

NA - 00841983100659

Electrode junction box (256 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983100659 ()
JE-120A-24

  • Electroencephalograph

NA - 00841983100642

Electrode junction box (192 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-23
In Commercial Distribution

  • 00841983100642 ()
JE-120A-23

  • Electroencephalograph

NA - 00841983100635

Electrode junction box (128 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-22
In Commercial Distribution

  • 00841983100635 ()
JE-120A-22

  • Electroencephalograph

NA - 00841983100628

Electrode junction box (64 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A
In Commercial Distribution

  • 00841983100628 ()
JE-120A-21

  • Electroencephalograph

Auto Segmentation - 00195278560384

MD Auto Segmentation for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278560384 ()
5919805

  • CT system application software

Tandem Source - 00389152106113

Tandem Source Web Application v 3.X
Tandem Diabetes Care, Inc.
1011061
In Commercial Distribution

  • 00389152106113 ()
1011061

  • Ambulatory insulin infusion pump software, data-display

Dexcom API - 00386270000668

Public API that allows access by authorized third parties to select Dexcom data
Dexcom, Inc.
SW13183
In Commercial Distribution

  • 00386270000668 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

CaloPix - 03760408001005

CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
TRIBUN HEALTH
6.1.0 IVDUS
In Commercial Distribution

  • 03760408001005 ()


  • Pathology information system
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