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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 - 04037691650326

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

  • 04037691650333 ()
  • 04037691650326 ()

  • connection size 3/8 Inch
70104.7553

  • Cardiopulmonary bypass system centrifugal pump

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

HUDSON RCI - 04026704588619

ET TUBE, EXCHANGER, TTX, 7.5 - 10.0 MM
TELEFLEX INCORPORATED
IPN044922
In Commercial Distribution

  • 24026704588613 ()
  • 04026704588619 ()
  • 44026704588617 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
  • Length: 810 Millimeter
5-24006

  • Endotracheal tube guide, single-use

HUDSON RCI - 04026704398249

ET TUBE, EXCHANGER, TTX, 6.0 - 8.5 MM
TELEFLEX INCORPORATED
IPN044921
In Commercial Distribution

  • 24026704398243 ()
  • 04026704398249 ()
  • 44026704398247 ()

  • Length: 810 Millimeter
  • Sheridan T.T.X. Tracheal Tube Exchanger
5-24004

  • Endotracheal tube guide, single-use

HUDSON RCI - 04026704398232

ET TUBE, EXCHANGER, TTX, 4.0 - 6.0 MM
TELEFLEX INCORPORATED
IPN044920
In Commercial Distribution

  • 44026704398230 ()
  • 24026704398236 ()
  • 04026704398232 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
  • Length: 810 Millimeter
5-24002

  • Endotracheal tube guide, single-use

HUDSON RCI - 04026704398225

ET TUBE, EXCHANGER, TTX, 2.5 - 3.5 MM
TELEFLEX INCORPORATED
IPN044919
In Commercial Distribution

  • 24026704398229 ()
  • 04026704398225 ()
  • 44026704398223 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
  • Length: 15 Millimeter
5-24000

  • Endotracheal tube guide, single-use

VitalFlow Centrifugal Pump - 10850007732346

The VitalFlow Centrifugal Pump is a blood pump designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. To limit friction and heat generation, the VitalFlow Centrifugal Pump utilizes a pivot bearing design on a dual ceramic pivot. The pump’s blood contacting surface is coated with Balance Biosurface which is a non-heparin biocompatible coating that reduces platelet adhesion. The VitalFlow Centrifugal Pump couples to a remote magnetic drive unit called the VitalFlow™ Motor Drive, which interfaces with a pump speed controller. It also couples with the VitalFlow™ Emergency Hand Crank in the event of controller or power failure.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58111
In Commercial Distribution

  • 10850007732346 ()
58111

  • Cardiopulmonary bypass system centrifugal pump

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 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 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

JEM 350 Endotracheal Tube Changer - M996JEM3500

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 350 fits tubes with 5.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 350
In Commercial Distribution

  • M996JEM3502 ()
  • M996JEM3500 ()

  • Outer Diameter: 4.55 Millimeter
JEM 350

  • Endotracheal tube guide, single-use

JEM 340 Endotracheal Tube Changer - M996JEM3400

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 340 fits tubes with 4.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 340
In Commercial Distribution

  • M996JEM3402 ()
  • M996JEM3400 ()

  • Outer Diameter: 3.56 Millimeter
JEM 340

  • Endotracheal tube guide, single-use

JEM 330 Endotracheal Tube Changer - M996JEM3300

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 330 fits tubes with 3.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 330
In Commercial Distribution

  • M996JEM3302 ()
  • M996JEM3300 ()

  • Outer Diameter: 2.57 Millimeter
JEM 330

  • Endotracheal tube guide, single-use

JEM 325 Endotracheal Tube Changer - M996JEM3250

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 325 fits tubes with 2.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 325
In Commercial Distribution

  • M996JEM3252 ()
  • M996JEM3250 ()

  • Outer Diameter: 1.80 Millimeter
JEM 325

  • 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 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 355 Endotracheal Tube Changer - M996JEM3550

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 355 fits tubes with 5.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 355
In Commercial Distribution

  • M996JEM3552 ()
  • M996JEM3550 ()

  • Outer Diameter: 4.55 Millimeter
JEM 355

  • Endotracheal tube guide, single-use

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

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
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