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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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Quantum SuperPAC Tubing set - SP07C-DA - 18051160302755

No Description
SPECTRUM MEDICAL SRL
SP07C-DA
Not in Commercial Distribution

  • 18051160302755 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Tubing Set - SP02C-BC - 18051160302045

No Description
SPECTRUM MEDICAL SRL
SP02C-BC
Not in Commercial Distribution

  • 18051160302045 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02V-BB - 18051160302014

No Description
SPECTRUM MEDICAL SRL
SP02V-BB
Not in Commercial Distribution

  • 18051160302014 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02V-AA - 18051160302007

No Description
SPECTRUM MEDICAL SRL
SP02V-AA
Not in Commercial Distribution

  • 18051160302007 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02E-CC - 18051160301994

No Description
SPECTRUM MEDICAL SRL
SP02E-CC
Not in Commercial Distribution

  • 18051160301994 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02E-BB - 18051160301987

No Description
SPECTRUM MEDICAL SRL
SP02E-BB
Not in Commercial Distribution

  • 18051160301987 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Blood Oxygenator VT75-E2 - 18051160301871

No Description
SPECTRUM MEDICAL SRL
VT75-E2
In Commercial Distribution

  • 18051160301871 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator VT75-E1 - 18051160301864

No Description
SPECTRUM MEDICAL SRL
VT75-E1
In Commercial Distribution

  • 18051160301864 ()


  • Extracorporeal membrane oxygenator

Annalise Triage - G140ANNALISEENTP40

Annalise Triage 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
3.4.1
In Commercial Distribution

  • G140ANNALISEENTP40 ()


  • Radiology DICOM image processing application software

Annalise Enterprise - G140ANNALISEENTP30

Annalise Enterprise 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
3.3.0
In Commercial Distribution

  • G140ANNALISEENTP30 ()


  • Radiology DICOM image processing application software
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