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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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Software, HL7 Sleepware G3, Web
Respironics, Inc.
Software, HL7 Sleepware G3, Web - 3
In Commercial Distribution

  • 00606959048942 ()
1117948

  • Clinical laboratory information system
Software, Sleepware G3 (Japan Only)
Respironics, Inc.
Sleepware G3 Software, (Japan Only) - 3
Not in Commercial Distribution

  • 00606959046955 ()
1121998

  • Polysomnography analyser
Software, Sleepware G3, Web download
Respironics, Inc.
Sleepware G3 Software, Web download - 3
In Commercial Distribution

  • 00606959045279 ()
1115720

  • Polysomnography analyser
Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder
Grael PSG System, no software
COMPUMEDICS LIMITED
Grael PSG
In Commercial Distribution

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph
Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph
Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph
SentrySuite Server Software Win 10
Jaeger Medical GmbH
V-577400-13
In Commercial Distribution

  • 04250892905914 ()
V-577400-13

  • Pulmonary function analysis system, adult
Osia™ Fitting Software 2
COCHLEAR LIMITED
P1348428
In Commercial Distribution

  • 09321502044905 ()
P1348428

  • Audiometric/hearing device software
Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software
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