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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
Articulating Introducer with detachable handle, latex free, single use, sterile, fits 6.5 and larger ID tubes
Tjb Medical, Inc.
10000-500
In Commercial Distribution

  • 00860009688407 ()


  • Endotracheal tube guide, single-use
No Description
NORTH EAST SCIENTIFIC INC
R-414-159
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 5 French
R-414-159

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-414-151
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 5 French
R-414-151

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-417-156
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 6 French
R-417-156

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-417-152
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Introducer Sheath Compatibility: 5 French
R-417-152

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-420-159
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 7 French
R-420-159

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-420-006
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Introducer Sheath Compatibility: 6 French
R-420-006

  • Atherectomy laser system beam guide-catheter, peripheral
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)
NORTH EAST SCIENTIFIC INC
R-410-154
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-410-152
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral
Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3-way stopcock for drawing of gas or air, 0.2 micron filters provide for sterilization of gas and/or air, and 60cc syringe pre-marked with mixture percentages to eliminate guesswork during prepping. Sterile, single use.
ESCALON MEDICAL CORP.
9060-61
In Commercial Distribution

  • 10853480006157 ()
  • 00853480006150 ()
TR9060-61

  • Vitreoretinal gas injection set
TUBING 1X26R CCS CIRC W/O BRG W/FP W/BP
MEDTRONIC, INC.
1X26R
Not in Commercial Distribution

  • 00721902163517 ()


  • Cardiopulmonary bypass system centrifugal pump
bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø6mm - 11mm
VYGON
5576.01
In Commercial Distribution

  • 33660812111585 ()
  • 03660812111584 ()
  • 53660812111589 ()
00557601

  • Endotracheal tube guide, single-use
bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø4mm - 5.5mm
VYGON
5576.02
In Commercial Distribution

  • 33660812110731 ()
  • 03660812110730 ()
  • 53660812110735 ()
00557602

  • Endotracheal tube guide, single-use
bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø2.5mm - 3.5mm
VYGON
5576.03
In Commercial Distribution

  • 33660812109513 ()
  • 03660812109512 ()
  • 53660812109517 ()
00557603

  • Endotracheal tube guide, single-use
BO-RF-32-USA#RotaFlow Centrifugal Pump with SOFTLINE Coating
Maquet Cardiopulmonary AG
Centrifugal Pump, SOFTLINE
In Commercial Distribution

  • 04037691650333 ()
  • 04037691650326 ()

  • connection size 3/8 Inch
70104.7553

  • Cardiopulmonary bypass system centrifugal pump
BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating
Maquet Cardiopulmonary AG
Centrifugal Pump, BIOLINE
In Commercial Distribution

  • 04037691530871 ()
  • 04037691530864 ()

  • connection size 3/8 Inch
70104.7554

  • Cardiopulmonary bypass system centrifugal pump
No Description
Maquet Cardiopulmonary AG
Centrifugal Pump, USA
In Commercial Distribution

  • 04037691000824 ()
  • 04037691123554 ()

  • connection size 3/8 Inch
70101.8066

  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP20V-VT
In Commercial Distribution

  • 08051160300846 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP22V-VT
In Commercial Distribution

  • 08051160300624 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP37V-V0
In Commercial Distribution

  • 28051160300611 ()
  • 08051160300617 ()


  • Cardiopulmonary bypass system centrifugal pump
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