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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

Tubing Pack - 00607567203952

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

  • 00607567203952 ()
701052324

  • 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

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

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

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

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

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

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

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

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

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

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

Turbo-Power Laser Atherectomy Catheter - 00813132026783

No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132026783 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power Laser Atherectomy Catheter - 00813132026776

No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132026776 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power™ - 00813132025397

Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050AA
In Commercial Distribution

  • 00813132025397 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power™ - 00813132025366

Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050AA
In Commercial Distribution

  • 00813132025366 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Power™ - 00813132024833

Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132024833 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite Laser Atherectomy Catheter - 00813132024819

No Description
Spectranetics Corporation
425-135-01
In Commercial Distribution

  • 00813132024819 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 112 Centimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite Laser Atherectomy Catheter - 00813132024796

No Description
Spectranetics Corporation
423-135-01
In Commercial Distribution

  • 00813132024796 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite Laser Atherectomy Catheter - 00813132024789

No Description
Spectranetics Corporation
425-011
In Commercial Distribution

  • 00813132024789 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 112 Centimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite Laser Atherectomy Catheter - 00813132024772

No Description
Spectranetics Corporation
423-001
In Commercial Distribution

  • 00813132024772 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite Laser Atherectomy Catheter - 00813132024765

No Description
Spectranetics Corporation
420-159
In Commercial Distribution

  • 00813132024765 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-159

  • Atherectomy laser system beam guide-catheter, peripheral
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