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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 - 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

Quantum - 05060434422453

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

  • 05060434422453 ()
51-000059-01

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434422316

Quantum Pump Frame 6 - Toronto
SPECTRUM MEDICAL LIMITED
QPF6
In Commercial Distribution

  • 05060434422316 ()
51-000095-00

  • Cardiopulmonary bypass system roller pump

Quantum - 05060434422262

Quantum Pump Frame 5 - Charlotte
SPECTRUM MEDICAL LIMITED
QPF5
In Commercial Distribution

  • 05060434422262 ()
51-000090-00

  • Cardiopulmonary bypass system roller pump

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

RELIANT® - 00643169164192

CATHETER REL46 US RELIANT BALLOON
MEDTRONIC, INC.
REL46
In Commercial Distribution

  • 00643169164192 ()

  • 10-46 MM Balloon Inflation Diameter
  • 12F Minimum Sheath Diameter
  • Length: 100.0 Centimeter


  • Peripheral angioplasty balloon catheter, basic

Vanguard - 00851616007538

The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Contego Medical, Inc.
5120x135
In Commercial Distribution

  • 00851616007538 ()
V1-5120-135-01

  • Peripheral angioplasty balloon catheter, basic
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