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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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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

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

FloPump - 00814321020452

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/FloProbe Kit (Non-Sterile)
Not in Commercial Distribution

  • 00814321020452 ()
6000N(KIT)

  • Cardiopulmonary bypass system centrifugal pump

FloPump - 00814321020445

The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500N
Not in Commercial Distribution

  • 00814321020445 ()
6500N

  • Cardiopulmonary bypass system centrifugal pump

FloPump - 00814321020148

The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400N
Not in Commercial Distribution

  • 00814321020148 ()
6400N

  • Cardiopulmonary bypass system centrifugal pump

FloPump - 00814321020124

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.
1/4" FloPump (Non-Sterile)
Not in Commercial Distribution

  • 00814321020124 ()
6300N

  • Cardiopulmonary bypass system centrifugal pump

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

Turbo Tandem™ - M2044821100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
482-110
Not in Commercial Distribution

  • M2044821100 ()

  • Length: 110 Centimeter
482-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Tandem™ - M2044721100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
472-110
Not in Commercial Distribution

  • M2044721100 ()

  • Length: 110 Centimeter
472-110

  • Atherectomy laser system beam guide-catheter, peripheral
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