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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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BIO-PUMP® - 00613994406934

PUMP 95171 BIOPUMP BP50 STER 3L 4PK
MEDTRONIC, INC.
95171
In Commercial Distribution

  • 20613994406938 ()
  • 00613994406934 ()


  • Cardiopulmonary bypass system centrifugal pump

TRILLIUM® BIO-PUMP+® - 00613994462503

PUMP BPX-80T BIOPUMP 6HR W/TRILLIUM 3L
MEDTRONIC, INC.
BPX-80T
Not in Commercial Distribution

  • 00613994462503 ()


  • Cardiopulmonary bypass system centrifugal pump

BIO-PUMP+® - 00613994529213

PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L
MEDTRONIC, INC.
CBBPX-80
Not in Commercial Distribution

  • 00613994529213 ()


  • Cardiopulmonary bypass system centrifugal pump

Thermogard HQTM Start-Up Kit EX - 00849111075879

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

Thermogard HQTM Start-Up Kit - 00849111075862

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

Affinity™ - 00643169272248

ADAPTER AP40AST AFFINITY CP WW
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00643169272248 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 00643169272231

ADAPTER AP40AST AFFINITY CP US
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00643169272231 ()


  • Cardiopulmonary bypass system centrifugal pump

Trillium™ Bio-Pump+™ - 00643169630628

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

Bio-Pump™ - 00643169630604

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

Bio-Pump+™ - 00643169630581

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
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