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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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No Description
Terumo Cardiovascular Systems Corporation
CV-164275
In Commercial Distribution

  • 50699753450337 ()
  • 00699753450332 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
Terumo Cardiovascular Systems Corporation
164275X
In Commercial Distribution

  • 50699753450320 ()
  • 00699753450325 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
Terumo Cardiovascular Systems Corporation
164275
In Commercial Distribution

  • 00699753002333 ()
  • 50699753002338 ()


  • 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
PUMP CBBPX-80 BIOPUMP 1EA CBBPX80 AD ST
MEDTRONIC, INC.
CBBPX-80
Not in Commercial Distribution

  • 00721902817403 ()


  • Cardiopulmonary bypass system centrifugal pump
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
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