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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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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

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

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

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

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

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

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

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

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

Turbo Tandem™ - M2044821100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
482-110
Not in Commercial Distribution

  • M2044821100 ()

  • Length: 110 Centimeter
482-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Tandem™ - M2044721100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
472-110
Not in Commercial Distribution

  • M2044721100 ()

  • Length: 110 Centimeter
472-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - M204425135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-135-01
Not in Commercial Distribution

  • M204425135010 ()

  • Outer Diameter: 2.6 Millimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044250010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011
Not in Commercial Distribution

  • M2044250010 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - M204423135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-135-01
Not in Commercial Distribution

  • M204423135010 ()

  • Outer Diameter: 2.3 Millimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044230010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-001
Not in Commercial Distribution

  • M2044230010 ()

  • Outer Diameter: 2.3 Millimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral
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