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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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Natus - 00382830019231

NEUROWORKS 8.1.1 SOFTWARE (US)
XLTEK
104196
In Commercial Distribution

  • 00382830019231 ()


  • Electroencephalograph

Natus - 00382830039475

SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


  • Electromyograph

Natus - 00382830038003

Synergy Software v20 CD
NATUS NEUROLOGY INCORPORATED
482-647500
In Commercial Distribution

  • 00382830038003 ()


  • Electromyograph

DirectView - 00606959028630

DirectView Software Version 2.4
Respironics, Inc.
DirectView PC Software Application, Web - 2
In Commercial Distribution

  • 00606959028630 ()
1063558

  • Medical equipment clinical data interfacing software

HL7 - 00606959039049

HL7 Forwarding Service Software
Respironics, Inc.
Software, HL7 Forwarding Service - 3
In Commercial Distribution

  • 00606959039049 ()
1104880

  • Clinical laboratory information system

Sleepware - 00606959039001

Sleepware G3 Software, Web
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959039001 ()
1115720

  • Polysomnography analyser

Omnilab Direct - 00606959038769

Software, OmniLab Direct, Web
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959038769 ()
1113127

  • Ventilator IMV controller

Sleepware - 00606959045262

Software, Sleepware G3 (Multi-Lingual)
Respironics, Inc.
Sleepware G3 Software, Multi-Lingual - 3
In Commercial Distribution

  • 00606959045262 ()
1082463

  • Polysomnography analyser

Sleepware - 00606959045255

Software, Sleepware G3 (EN)
Respironics, Inc.
Sleepware G3 Software, English - 3
In Commercial Distribution

  • 00606959045255 ()
1082462

  • Polysomnography analyser

Omnilab Direct - 00606959044296

OmniLab Direct Software, Web
Respironics, Inc.
OmniLab Direct, Web Software - 2
In Commercial Distribution

  • 00606959044296 ()
1113127

  • Clinical laboratory information system
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