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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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Electrode junction box standard composition
NIHON KOHDEN CORPORATION
JE-921A
In Commercial Distribution

  • 04931921112076 ()
JE-921A

  • Electroencephalograph
Mini electrode junction box (10-20 type, 64)
NIHON KOHDEN CORPORATION
JE-208A
In Commercial Distribution

  • 04931921103029 ()
JE-208A

  • Electroencephalograph
Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep.
Signalitica Inc
v 1.1
In Commercial Distribution

  • 00627987257502 ()


  • Sleep disorder interpretive software, professional-only
No Description
Nox Medical ehf.
DEEPRESP
In Commercial Distribution

  • 15694311112099 ()


  • Sleep disorder interpretive software, professional-only
ASSEMBLY PKGD LIPIVIEW 1 - INTL
TEARSCIENCE, INC.
LVI-1001
In Commercial Distribution

  • 00859623006513 ()
100000

  • Ophthalmic interferometer
Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Software Upgrade, LiDCO LXI v2 for ICU Medical only (b1328)
LIDCO LIMITED
Li11152
In Commercial Distribution

  • 05060110522620 ()
Li11152

  • General-purpose multi-parameter bedside monitor
Licence +SC, Software, LiDCOplus, requires LFM Smartcard (Plus, Li, Ext)
LIDCO LIMITED
Li11082
In Commercial Distribution

  • 05060110522392 ()
Li11082

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOrapid, Li Calibration (Rapid, Li, CNAP, BIS, Ext)
LIDCO LIMITED
Li11077
In Commercial Distribution

  • 05060110522347 ()
Li11077

  • General-purpose multi-parameter bedside monitor
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