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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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Sarns™ Centrifugal Pump without X-Coating™ - 00699753002333

No Description
Terumo Cardiovascular Systems Corporation
164275
In Commercial Distribution

  • 00699753002333 ()
  • 50699753002338 ()


  • Cardiopulmonary bypass system centrifugal pump

Intersept® Custom Tubing Pack - 00721902163517

TUBING 1X26R CCS CIRC W/O BRG W/FP W/BP
MEDTRONIC, INC.
1X26R
Not in Commercial Distribution

  • 00721902163517 ()


  • Cardiopulmonary bypass system centrifugal pump

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399123

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


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 5 French
R-414-159

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399116

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


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 5 French
R-414-151

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399109

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


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 6 French
R-417-156

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399093

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


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Introducer Sheath Compatibility: 5 French
R-417-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399086

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


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 7 French
R-420-159

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399079

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


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Introducer Sheath Compatibility: 6 French
R-420-006

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399062

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


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

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399055

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


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

  • Atherectomy laser system beam guide-catheter, peripheral

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

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

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

ROTAFLOW - 04037691123554

No Description
Maquet Cardiopulmonary AG
Centrifugal Pump, USA
In Commercial Distribution

  • 04037691000824 ()
  • 04037691123554 ()

  • connection size 3/8 Inch
70101.8066

  • Cardiopulmonary bypass system centrifugal pump

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

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
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