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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 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

JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes) - M996JEM4010

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 401 is a set of nine individually packaged endotracheal tube changers, with each fitting a different size endotracheal tube. The JEM 401 includes one each of JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 401
In Commercial Distribution

  • M996JEM4010 ()

  • Outer Diameter: 6.43 Millimeter
  • Outer Diameter: 5.54 Millimeter
  • Outer Diameter: 4.55 Millimeter
  • Outer Diameter: 3.56 Millimeter
  • Outer Diameter: 2.57 Millimeter
  • Outer Diameter: 1.80 Millimeter
JEM 401

  • Endotracheal tube guide, single-use

JEM 400 Endotracheal Tube Changer - M996JEM4000

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 400 fits tubes with 7.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 400
In Commercial Distribution

  • M996JEM4002 ()
  • M996JEM4000 ()

  • Outer Diameter: 6.43 Millimeter
JEM 400

  • Endotracheal tube guide, single-use

JEM 370 Endotracheal Tube Changer - M996JEM3700

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 370 fits tubes with 7.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 370
In Commercial Distribution

  • M996JEM3702 ()
  • M996JEM3700 ()

  • Outer Diameter: 5.54 Millimeter
JEM 370

  • Endotracheal tube guide, single-use

JEM 365 Endotracheal Tube Changer - M996JEM3650

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 365 fits tubes with 6.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 365
In Commercial Distribution

  • M996JEM3652 ()
  • M996JEM3650 ()

  • Outer Diameter: 5.54 Millimeter
JEM 365

  • Endotracheal tube guide, single-use

JEM 360 Endotracheal Tube Changer - M996JEM3600

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 360 fits tubes with 6.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 360
In Commercial Distribution

  • M996JEM3602 ()
  • M996JEM3600 ()

  • Outer Diameter: 5.54 Millimeter
JEM 360

  • Endotracheal tube guide, single-use
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