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

  • 20613994647850 ()
  • 00613994647856 ()


  • Cardiopulmonary bypass system centrifugal pump
The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
Zoll Circulation, Inc.
TG2-500D, Extended Length
In Commercial Distribution

  • 00849111075879 ()

  • Length: 9 Feet
8700-001028-01

  • Intravascular core temperature regulation system start kit
The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
Zoll Circulation, Inc.
TG2-500D
In Commercial Distribution

  • 00849111075862 ()

  • Length: 6 Feet
8700-001027-01

  • Intravascular core temperature regulation system start kit
PUMP BPX-80T BIOPUMP 6HR W/TRILLIUM 3L
MEDTRONIC, INC.
BPX-80T
Not in Commercial Distribution

  • 00643169630628 ()

  • Lumen/Inner Diameter: 9.53 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L
MEDTRONIC, INC.
CBBP50
In Commercial Distribution

  • 00643169630604 ()

  • Lumen/Inner Diameter: 6.35 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
MEDTRONIC, INC.
CBBPX-80
In Commercial Distribution

  • 00643169630581 ()

  • Lumen/Inner Diameter: 9.53 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
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
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
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
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
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