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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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Sandman Codec Software V.2.0 CD-Elite
Embla Systems Ltd
4120082
In Commercial Distribution

  • 00382830023924 ()


  • Sleep disorder interpretive software
BD FACSDiva™ Software v 9.2
Becton, Dickinson And Company
665421
In Commercial Distribution

  • 00382906654212 ()
665421

  • Laboratory instrument/analyser application software IVD
BD FACSCanto II System Software V2.4
BECTON, DICKINSON AND COMPANY
646601
Not in Commercial Distribution

  • 00382906466013 ()
646601

  • Laboratory instrument/analyser application software IVD
HL7 Software for Sleepware G3, Web
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959038967 ()
1117948

  • Clinical laboratory information system
Sleepware G3 Software Package, Multi Lingual
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004856 ()
1082463

  • Polysomnography analyser
MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software
SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
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