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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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FloPump - 00814321020001

The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Non-Sterile)
Not in Commercial Distribution

  • 00814321020001 ()
6000N

  • Cardiopulmonary bypass system centrifugal pump

TandemHeart - 00814112020043

TandemHeart blood pump
CARDIACASSIST, INC.
2100-0113
Not in Commercial Distribution

  • 00814112020043 ()


  • Cardiopulmonary bypass system centrifugal pump

Turbo-Power Laser Atherectomy Catheter - 00813132029951

No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132029951 ()

  • Outer Diameter: 2.3 Millimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power Laser Atherectomy Catheter - 00813132029944

No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132029944 ()

  • Outer Diameter: 2.0 Millimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral

Affinity™ - 00763000134563

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20763000134567 ()
  • 00763000134563 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ - 00763000134556

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
Not in Commercial Distribution

  • 20763000134550 ()
  • 00763000134556 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ - 00763000134532

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20763000134536 ()
  • 00763000134532 ()


  • Cardiopulmonary bypass system centrifugal pump

Turbo-Power Laser Atherectomy Catheter - 00813132026783

No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132026783 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power Laser Atherectomy Catheter - 00813132026776

No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132026776 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power™ - 00813132025397

Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050AA
In Commercial Distribution

  • 00813132025397 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
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