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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

Affinity™ CP - 00643169855212

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

  • 20643169855216 ()
  • 00643169855212 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 00643169855205

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20643169855209 ()
  • 00643169855205 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 00643169855199

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20643169855193 ()
  • 00643169855199 ()


  • Cardiopulmonary bypass system centrifugal pump

Bio-Pump+™ - 00643169794795

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

Bio-Pump™ - 00643169794771

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

Affinity™ CP - 00613994647863

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

  • 20613994647867 ()
  • 00613994647863 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 00613994647856

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20613994647850 ()
  • 00613994647856 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 00613994647849

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20613994647843 ()
  • 00613994647849 ()


  • Cardiopulmonary bypass system centrifugal pump

Tubing Pack - 00607567203952

BO-RF32 Rotaflow
DATASCOPE CORP.
BO-T 6600
Not in Commercial Distribution

  • 00607567203952 ()
701052324

  • Cardiopulmonary bypass system centrifugal pump

QuickSteer Introducer - 00860009688407

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

HUDSON RCI - 14026704617941

ET TUBE, EXCHANGER, TTX, 7.5 - 10.0 MM
TELEFLEX INCORPORATED
IPN049131
In Commercial Distribution

  • 34026704617945 ()
  • 14026704617941 ()
  • 44026704617942 ()
  • 04026704588619 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
5-24006

  • Endotracheal tube guide, single-use

HUDSON RCI - 14026704617934

ET TUBE, EXCHANGER, TTX, 6.0 - 8.5 MM
TELEFLEX INCORPORATED
IPN049130
In Commercial Distribution

  • 44026704617935 ()
  • 34026704617938 ()
  • 14026704617934 ()
  • 04026704398249 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
5-24004

  • Endotracheal tube guide, single-use

HUDSON RCI - 14026704617927

ET TUBE, EXCHANGER, TTX, 4.0 - 6.0 MM
TELEFLEX INCORPORATED
IPN049129
In Commercial Distribution

  • 44026704617928 ()
  • 34026704617921 ()
  • 14026704617927 ()
  • 04026704398232 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
5-24002

  • Endotracheal tube guide, single-use

BIO-PUMP+® - 00721902817403

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

  • 00721902817403 ()


  • Cardiopulmonary bypass system centrifugal pump

Universal Gas Mixing Kit - 00853480006150

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

Capiox® iCP Centrifugal Pump - 00699753450974

No Description
Terumo Cardiovascular Systems Corporation
3CX*CP8J
In Commercial Distribution

  • 50699753450979 ()
  • 00699753450974 ()


  • Cardiopulmonary bypass system centrifugal pump

Capiox® iCP Centrifugal Pump - 00699753450967

No Description
Terumo Cardiovascular Systems Corporation
3CX*CP8
In Commercial Distribution

  • 50699753450962 ()
  • 00699753450967 ()


  • Cardiopulmonary bypass system centrifugal pump

Sarns™ Centrifugal Pump with X-Coating™ - 00699753450349

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

  • 50699753450344 ()
  • 00699753450349 ()


  • Cardiopulmonary bypass system centrifugal pump

Sarns™ Centrifugal Pump without X-Coating™ - 00699753450332

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

  • 50699753450337 ()
  • 00699753450332 ()


  • Cardiopulmonary bypass system centrifugal pump

Sarns™ Centrifugal Pump with X-Coating™ - 00699753450325

No Description
Terumo Cardiovascular Systems Corporation
164275X
In Commercial Distribution

  • 50699753450320 ()
  • 00699753450325 ()


  • Cardiopulmonary bypass system centrifugal pump

Sarns™ Centrifugal Pump without X-Coating™ - 00699753002333

No Description
Terumo Cardiovascular Systems Corporation
164275
In Commercial Distribution

  • 00699753002333 ()
  • 50699753002338 ()


  • Cardiopulmonary bypass system centrifugal pump

Intersept® Custom Tubing Pack - 00721902163517

TUBING 1X26R CCS CIRC W/O BRG W/FP W/BP
MEDTRONIC, INC.
1X26R
Not in Commercial Distribution

  • 00721902163517 ()


  • Cardiopulmonary bypass system centrifugal pump

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399123

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

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399116

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

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399109

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

NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399093

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

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399086

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

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399079

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

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399062

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

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - 00850044399055

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

VitalFlow Centrifugal Pump - 10850007732346

The VitalFlow Centrifugal Pump is a blood pump designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. To limit friction and heat generation, the VitalFlow Centrifugal Pump utilizes a pivot bearing design on a dual ceramic pivot. The pump’s blood contacting surface is coated with Balance Biosurface which is a non-heparin biocompatible coating that reduces platelet adhesion. The VitalFlow Centrifugal Pump couples to a remote magnetic drive unit called the VitalFlow™ Motor Drive, which interfaces with a pump speed controller. It also couples with the VitalFlow™ Emergency Hand Crank in the event of controller or power failure.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58111
In Commercial Distribution

  • 10850007732346 ()
58111

  • Cardiopulmonary bypass system centrifugal pump

HUDSON RCI - 04026704588619

ET TUBE, EXCHANGER, TTX, 7.5 - 10.0 MM
TELEFLEX INCORPORATED
IPN044922
In Commercial Distribution

  • 24026704588613 ()
  • 04026704588619 ()
  • 44026704588617 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
  • Length: 810 Millimeter
5-24006

  • Endotracheal tube guide, single-use

ROTAFLOW - 04037691650326

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

ROTAFLOW - 04037691530864

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

ROTAFLOW - 04037691123554

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

HUDSON RCI - 04026704398249

ET TUBE, EXCHANGER, TTX, 6.0 - 8.5 MM
TELEFLEX INCORPORATED
IPN044921
In Commercial Distribution

  • 24026704398243 ()
  • 04026704398249 ()
  • 44026704398247 ()

  • Length: 810 Millimeter
  • Sheridan T.T.X. Tracheal Tube Exchanger
5-24004

  • Endotracheal tube guide, single-use

HUDSON RCI - 04026704398232

ET TUBE, EXCHANGER, TTX, 4.0 - 6.0 MM
TELEFLEX INCORPORATED
IPN044920
In Commercial Distribution

  • 44026704398230 ()
  • 24026704398236 ()
  • 04026704398232 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
  • Length: 810 Millimeter
5-24002

  • Endotracheal tube guide, single-use

HUDSON RCI - 04026704398225

ET TUBE, EXCHANGER, TTX, 2.5 - 3.5 MM
TELEFLEX INCORPORATED
IPN044919
In Commercial Distribution

  • 24026704398229 ()
  • 04026704398225 ()
  • 44026704398223 ()

  • Sheridan T.T.X. Tracheal Tube Exchanger
  • Length: 15 Millimeter
5-24000

  • Endotracheal tube guide, single-use

VYGON - 03660812111584

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

VYGON - 03660812110730

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
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