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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

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

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 - 00814321020438

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.
6500S
Not in Commercial Distribution

  • 00814321020438 ()
6500S

  • 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 - 00814321020131

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.
6400S
Not in Commercial Distribution

  • 00814321020131 ()
6400S

  • 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 - 00814321020117

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 (Sterile)
Not in Commercial Distribution

  • 00814321020117 ()
6300S

  • Cardiopulmonary bypass system centrifugal pump

FloPump - 00814321020100

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/FloProbe Kit (Sterile)
Not in Commercial Distribution

  • 00814321020100 ()
6300S(KIT)

  • Cardiopulmonary bypass system centrifugal pump

FloPump - 00814321020094

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 (Sterile)
Not in Commercial Distribution

  • 00814321020094 ()
6000S(KIT)

  • Cardiopulmonary bypass system centrifugal pump

FloPump - 00814321020018

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 (Sterile)
Not in Commercial Distribution

  • 00814321020018 ()
6000S

  • Cardiopulmonary bypass system centrifugal pump

TandemHeart - 00814112020043

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

  • 00814112020043 ()


  • Cardiopulmonary bypass system centrifugal pump

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3683

No Description
NORTH EAST SCIENTIFIC INC
R-420-006
In Commercial Distribution

  • B227NRP3683 ()
R-420-006

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3682

No Description
NORTH EAST SCIENTIFIC INC
R-417-152
In Commercial Distribution

  • B227NRP3682 ()
R-417-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3681

No Description
NORTH EAST SCIENTIFIC INC
R-414-151
In Commercial Distribution

  • B227NRP3681 ()
R-414-151

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - B227NRP3680

No Description
NORTH EAST SCIENTIFIC INC
R-410-152
In Commercial Distribution

  • B227NRP3680 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1303

No Description
NORTH EAST SCIENTIFIC INC
R-420-159
In Commercial Distribution

  • B227NRP1303 ()
R-420-159

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1302

No Description
NORTH EAST SCIENTIFIC INC
R-417-156
In Commercial Distribution

  • B227NRP1302 ()
R-417-156

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1301

No Description
NORTH EAST SCIENTIFIC INC
R-414-159
In Commercial Distribution

  • B227NRP1301 ()
R-414-159

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1300

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
In Commercial Distribution

  • B227NRP1300 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral

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

VYGON - 03660812111584

bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø6mm - 11mm
VYGON
5576.01
In Commercial Distribution

  • 33660812111585 ()
  • 03660812111584 ()
  • 53660812111589 ()
00557601

  • Endotracheal tube guide, single-use

VYGON - 03660812110730

bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø4mm - 5.5mm
VYGON
5576.02
In Commercial Distribution

  • 33660812110731 ()
  • 03660812110730 ()
  • 53660812110735 ()
00557602

  • Endotracheal tube guide, single-use

VYGON - 03660812109512

bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø2.5mm - 3.5mm
VYGON
5576.03
In Commercial Distribution

  • 33660812109513 ()
  • 03660812109512 ()
  • 53660812109517 ()
00557603

  • Endotracheal tube guide, single-use

Affinity™ CP - 20643169785780

PUMP CBAP40 AFF CP CENTRIF CC US/CAN 4PK
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20643169785780 ()
  • 00643169785786 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433254

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

  • 20643169433254 ()
  • 00643169433250 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433247

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
Not in Commercial Distribution

  • 20643169433247 ()
  • 00643169433243 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433230

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20643169433230 ()
  • 00643169433236 ()


  • Cardiopulmonary bypass system centrifugal pump

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 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 Elite™ - M204425135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-135-01
Not in Commercial Distribution

  • M204425135010 ()

  • Outer Diameter: 2.6 Millimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044250010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011
Not in Commercial Distribution

  • M2044250010 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044230010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-001
Not in Commercial Distribution

  • M2044230010 ()

  • Outer Diameter: 2.3 Millimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral
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