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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