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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 - 05060434422026

Quantum Workstation Lite - 15"
SPECTRUM MEDICAL LIMITED
QWSL
In Commercial Distribution

  • 05060434422026 ()
51-000080-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434420954

Quantum Pump Frame 4 - New York
SPECTRUM MEDICAL LIMITED
QPF4
In Commercial Distribution

  • 05060434420954 ()
51-000059-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434420824

Quantum Pump Frame 3 - Vienna
SPECTRUM MEDICAL LIMITED
QPF3
In Commercial Distribution

  • 05060434420824 ()
51-000056-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434420800

Quantum Pump Control Module
SPECTRUM MEDICAL LIMITED
QCM
In Commercial Distribution

  • 05060434420800 ()
51-000003-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434420787

Quantum Roller Pump - 6 inch
SPECTRUM MEDICAL LIMITED
QRP6
In Commercial Distribution

  • 05060434420787 ()
51-000013-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434420770

Quantum Roller Pump - 8 inch
SPECTRUM MEDICAL LIMITED
QRP8
In Commercial Distribution

  • 05060434420770 ()
51-000008-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434420763

Quantum Power Supply
SPECTRUM MEDICAL LIMITED
QPS
In Commercial Distribution

  • 05060434420763 ()
51-000021-00

  • Cardiopulmonary bypass system roller pump

Quantum ® - 05060434420756

Quantum Pump Frame 2 - Cheltenham
SPECTRUM MEDICAL LIMITED
QPF2
In Commercial Distribution

  • 05060434420756 ()
51-000025-00

  • Cardiopulmonary bypass system roller pump

EverCross™ - 00643169973329

PTA AB35W03120080 EVERCROSS 035 V08
EV3, INC
AB35W03120080
In Commercial Distribution

  • 00643169973329 ()

  • 0.89 MM Max. Guidewire
  • 3 MM Balloon Diameter
  • Catheter Gauge: 5.0 French
  • Catheter Working Length: 80.0 Centimeter
  • 120 MM Balloon Length


  • Peripheral angioplasty balloon catheter, basic

EverCross™ - 00643169973312

PTA AB35W03100135 EVERCROSS 035 V08
EV3, INC
AB35W03100135
In Commercial Distribution

  • 00643169973312 ()

  • 3 MM Balloon Diameter
  • 0.89 MM Max. Guidewire
  • Catheter Gauge: 5.0 French
  • Catheter Working Length: 135.0 Centimeter
  • 100 MM Balloon Length


  • Peripheral angioplasty balloon catheter, basic
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