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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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BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTP1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360ECTA1130 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360ECTA1110 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.3
In Commercial Distribution

  • B720BX360EASPECTS113 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution

  • B720BX360EASPECTS1110 ()


  • X-ray image interpretive software
CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
CXR - 2.4+
In Commercial Distribution

  • G140ANNALISECONTAINER60 ()
Annalisecontainer6

  • X-ray image interpretive software
Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.2m
SPECTRUM MEDICAL LIMITED
QFS4-ST-120
In Commercial Distribution

  • 05060434423269 ()
51-000135-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.2m
SPECTRUM MEDICAL LIMITED
QFS2-ST-120
In Commercial Distribution

  • 05060434423245 ()
51-000133-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.75m Right Angled
SPECTRUM MEDICAL LIMITED
QFS5-RA-075
In Commercial Distribution

  • 05060434423221 ()
51-000131-00

  • Cardiopulmonary bypass system air bubble/fluid level detector
Quantum Workstation 15" Lite
SPECTRUM MEDICAL LIMITED
QWS15L
In Commercial Distribution

  • 05060434422279 ()
51-000091-00

  • Extracorporeal blood gas/pH monitor
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