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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 ® System M ® - 05060434420107

Tube ID 1/4" x Wall 1/16" (OD 3/8")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420107 ()
H6XLE

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420091

Tube ID 3/16" x Wall 1/16" (OD 5/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420091 ()
H5XLA

  • Extracorporeal blood gas/pH monitor

Quantum Perfusion Capnometer Line Set - 08051160302130

No Description
SPECTRUM MEDICAL SRL
CAP-SP1
In Commercial Distribution

  • 08051160302130 ()


  • Gas-sampling/monitoring respiratory tubing, single-use

Quantum SuperPAC Tubing Set - SP03E-AA - 08051160301706

No Description
SPECTRUM MEDICAL SRL
SP03E-AA
Not in Commercial Distribution

  • 08051160301706 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02E-AA - 08051160301690

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

  • 08051160301690 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP01V-AA - 08051160301522

No Description
SPECTRUM MEDICAL SRL
SP01V-AA
Not in Commercial Distribution

  • 08051160301522 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP01C-DA - 08051160301492

No Description
SPECTRUM MEDICAL SRL
SP01C-DA
Not in Commercial Distribution

  • 08051160301492 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP01E-AA - 08051160301461

No Description
SPECTRUM MEDICAL SRL
SP01E-AA
Not in Commercial Distribution

  • 08051160301461 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Arterial Cannula Graft - 08051160300839

No Description
SPECTRUM MEDICAL SRL
AG08-V0
In Commercial Distribution

  • 08051160300839 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Quantum Perfusion Blood Oxygenator VT160-E2 - 08051160300747

No Description
SPECTRUM MEDICAL SRL
VT160-E2
In Commercial Distribution

  • 08051160300747 ()


  • Extracorporeal membrane oxygenator
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