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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 Perfusion SuperPAC Tubing set - SP05E-AA - 18051160302717

No Description
SPECTRUM MEDICAL SRL
SP05E-AA
In Commercial Distribution

  • 18051160302717 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Dual Lumen Cannula 31F-V1 - 18051160302694

No Description
SPECTRUM MEDICAL SRL
DL31F-V1
In Commercial Distribution

  • 18051160302694 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum Perfusion Centrifugal Blood Pump CP20 - 18051160302144

No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump

STARKEY - 00842318189738

No Description
Starkey Laboratories, Inc.
EVOLV AI CIC
In Commercial Distribution

  • 00842318189738 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal

Sunquest Application Interfacing - B236AI5300

Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information
CliniSys, Inc
5.3
Not in Commercial Distribution

  • B236AI5300 ()


  • Clinical laboratory information system application software

Quantum PureFlow KIT CPC - Hansen Connector Adaptor - 08051160301577

No Description
SPECTRUM MEDICAL SRL
CONN-HX2
In Commercial Distribution

  • 08051160301577 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow KIT CPC - Barbed Connector Adaptor - 08051160301560

No Description
SPECTRUM MEDICAL SRL
CONN-HX1
In Commercial Distribution

  • 08051160301560 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum SuperPAC Cardioplegia Set 3/16 - PL - 08051160301386

No Description
SPECTRUM MEDICAL SRL
CGSP2-P1
Not in Commercial Distribution

  • 08051160301386 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Cardioplegia Set 1/4 - PL - 08051160301379

No Description
SPECTRUM MEDICAL SRL
CGSP2-P0
Not in Commercial Distribution

  • 08051160301379 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Cardioplegia Tubing Set 1/4 - 18051160302793

No Description
SPECTRUM MEDICAL SRL
CGSP7-B0
Not in Commercial Distribution

  • 18051160302793 ()


  • Cardioplegia solution administration kit
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