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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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ROTAFLOW - 04037691530864

BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating
Maquet Cardiopulmonary AG
Centrifugal Pump, BIOLINE
In Commercial Distribution

  • 04037691530871 ()
  • 04037691530864 ()

  • connection size 3/8 Inch
70104.7554

  • Cardiopulmonary bypass system centrifugal pump

ROTAFLOW - 04037691123554

No Description
Maquet Cardiopulmonary AG
Centrifugal Pump, USA
In Commercial Distribution

  • 04037691000824 ()
  • 04037691123554 ()

  • connection size 3/8 Inch
70101.8066

  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors - 08051160300846

No Description
SPECTRUM MEDICAL SRL
CP20V-VT
In Commercial Distribution

  • 08051160300846 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors - 08051160300624

No Description
SPECTRUM MEDICAL SRL
CP22V-VT
In Commercial Distribution

  • 08051160300624 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum PureFlow Centrifugal Blood Pump CP37 - 08051160300617

No Description
SPECTRUM MEDICAL SRL
CP37V-V0
In Commercial Distribution

  • 28051160300611 ()
  • 08051160300617 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum PureFlow Centrifugal Blood Pump CP22 - 08051160300600

No Description
SPECTRUM MEDICAL SRL
CP22V-V0
In Commercial Distribution

  • 28051160300604 ()
  • 08051160300600 ()


  • Cardiopulmonary bypass system centrifugal pump

PEDIMAG BLOOD PUMP - 07640135140634

No Description
Thoratec Switzerland GmbH
201-90052
In Commercial Distribution

  • 07640135140634 ()
201-90052

  • Cardiopulmonary bypass system centrifugal pump

CentriMag™ - 07640135140627

Blood Pump
Thoratec Switzerland GmbH
102953
In Commercial Distribution

  • 07640135140627 ()
102953

  • Cardiopulmonary bypass system centrifugal pump

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368

The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - NRP130

The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution

  • NRP130 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French


  • Atherectomy laser system beam guide-catheter, peripheral
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