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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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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
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
PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20613994647867 ()
  • 00613994647863 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20613994647850 ()
  • 00613994647856 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20613994647843 ()
  • 00613994647849 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP 95171 BIOPUMP BP50 STER 3L 4PK
MEDTRONIC, INC.
95171
In Commercial Distribution

  • 20613994406938 ()
  • 00613994406934 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L
MEDTRONIC, INC.
CBBP50
Not in Commercial Distribution

  • 00613994413031 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
MEDTRONIC, INC.
CBBPX-80
Not in Commercial Distribution

  • 00613994413024 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK
MEDTRONIC, INC.
95201
In Commercial Distribution

  • 20613994406945 ()
  • 00613994406941 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BPX-80T BIOPUMP 6HR W/TRILLIUM 3L
MEDTRONIC, INC.
BPX-80T
Not in Commercial Distribution

  • 00613994462503 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
MEDTRONIC, INC.
CBBPX-80
Not in Commercial Distribution

  • 00613994529213 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK
MEDTRONIC, INC.
95201
In Commercial Distribution

  • 20643169794799 ()
  • 00643169794795 ()

  • Lumen/Inner Diameter: 9.53 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
PUMP 95171 BIOPUMP BP50 STER 3L 4PK
MEDTRONIC, INC.
95171
In Commercial Distribution

  • 20643169794775 ()
  • 00643169794771 ()

  • Lumen/Inner Diameter: 6.35 Millimeter


  • Cardiopulmonary bypass system centrifugal pump
No Description
Terumo Cardiovascular Systems Corporation
3CX*CP8J
In Commercial Distribution

  • 50699753450979 ()
  • 00699753450974 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
Terumo Cardiovascular Systems Corporation
3CX*CP8
In Commercial Distribution

  • 50699753450962 ()
  • 00699753450967 ()


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

  • 50699753450344 ()
  • 00699753450349 ()


  • Cardiopulmonary bypass system centrifugal pump
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
PUMP CBBPX-80 BIOPUMP 1EA CBBPX80 AD ST
MEDTRONIC, INC.
CBBPX-80
Not in Commercial Distribution

  • 00721902817403 ()


  • Cardiopulmonary bypass system centrifugal pump
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