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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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MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358216

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.50 mm x 13 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC25013
In Commercial Distribution

  • 18906029358216 ()

  • Length: 13 Millimeter
  • Outer Diameter: 2.50 Millimeter
MNC25013

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358193

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.50 mm x 08 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC25008
In Commercial Distribution

  • 18906029358193 ()

  • Length: 8 Millimeter
  • Outer Diameter: 2.50 Millimeter
MNC25008

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358179

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.25 mm x 28 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC22528
In Commercial Distribution

  • 18906029358179 ()

  • Length: 28 Millimeter
  • Outer Diameter: 2.25 Millimeter
MNC22528

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358148

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.25 mm x 15 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC22515
In Commercial Distribution

  • 18906029358148 ()

  • Length: 15 Millimeter
  • Outer Diameter: 2.25 Millimeter
MNC22515

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358124

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.25 mm x 10 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC22510
In Commercial Distribution

  • 18906029358124 ()

  • Length: 10 Millimeter
  • Outer Diameter: 2.25 Millimeter
MNC22510

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358100

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.00 mm x 30 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC20030
In Commercial Distribution

  • 18906029358100 ()

  • Length: 30 Millimeter
  • Outer Diameter: 2.00 Millimeter
MNC20030

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358087

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.00 mm x 23 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC20023
In Commercial Distribution

  • 18906029358087 ()

  • Length: 23 Millimeter
  • Outer Diameter: 2.00 Millimeter
MNC20023

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358063

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.00 mm x 15 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC20015
In Commercial Distribution

  • 18906029358063 ()

  • Length: 15 Millimeter
  • Outer Diameter: 2.00 Millimeter
MNC20015

  • Coronary angioplasty balloon catheter, basic

MozecTM NC Rx PTCA Balloon Dilatation Catheter - 18906029358032

MozecTM NC Rx PTCA Balloon Dilatation Catheter, 2.00 mm x 08 mm, Rapid Exchange
MERIL LIFE SCIENCES PRIVATE LIMITED
MNC20008
In Commercial Distribution

  • 18906029358032 ()

  • Length: 8 Millimeter
  • Outer Diameter: 2.00 Millimeter
MNC20008

  • Coronary angioplasty balloon catheter, basic

InQwire® Amplatz - 00884450239681

No Description
Merit Medical Systems, Inc.
00884450239681
In Commercial Distribution

  • 20884450239685 ()
  • 10884450239688 ()
  • 00884450239681 ()

  • Configuration-Amplatz Exchange
  • Length-260 cm (102")
  • Tip Shape-Straight (7.0 cm) Tip
  • Tip Shape-Straight (7.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102"); Tip Shape-Straight (7.0 cm) Tip
  • Length-260 cm (102"); Configuration-Amplatz Exchange; Length-260 cm (102"); Tip Shape-Straight (7.0 cm) Tip
IQA526

  • Cardiac/peripheral vascular guidewire, single-use

Start-Up Kit Extended Length, Custom Luer - 00849111075350

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D EX
In Commercial Distribution

  • 00849111075350 ()

  • Length: 9 Feet
8700-0785-01

  • Intravascular core temperature regulation system start kit

Start-Up Kit Extended Length - 00849111075343

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D EX
In Commercial Distribution

  • 00849111075343 ()

  • Length: 9 Feet
8700-0667-01

  • Intravascular core temperature regulation system start kit

Start-Up Kit Custom Luer - 00849111075336

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D
In Commercial Distribution

  • 00849111075336 ()

  • Length: 6 Feet
8700-0784-01

  • Intravascular core temperature regulation system start kit

Start-Up Kit - 00849111075329

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D
In Commercial Distribution

  • 00849111075329 ()

  • Length: 6 Feet
8700-0666-01

  • Intravascular core temperature regulation system start kit

Start-Up Kit Japan - 00849111050081

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D
In Commercial Distribution

  • 00849111050081 ()

  • Length: 9 Feet
8700-0785-03

  • Intravascular core temperature regulation system start kit

Start-Up Kit - 00849111050029

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D
In Commercial Distribution

  • 00849111050029 ()

  • Length: 6 Feet
8700-0666-03

  • Intravascular core temperature regulation system start kit

Bio30+ System Physio Accel - 05056336800192

Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software
BIOCHROM LIMITED
80-6000-50
In Commercial Distribution

  • 05056336800192 ()


  • Amino acid analyser IVD

NA - 00681490408424

MOTOR 95120-004 EXT.DR MOTOR,540T, 3L
MEDTRONIC, INC.
95120-004
In Commercial Distribution

  • 00681490408424 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00681490408400

MOTOR 95120-003 BIOCONSOLE1EA 540TEFIDE
MEDTRONIC, INC.
95120-003
In Commercial Distribution

  • 00681490408400 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00643169315839

CONSOLE 560BC1 CONTROL WO/SAFETY BRD MEE
MEDTRONIC, INC.
560BC1
In Commercial Distribution

  • 00643169315839 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00643169315822

CONSOLE 560BCS1 CONTROL W/SAFETY BRD MEE
MEDTRONIC, INC.
560BCS1
In Commercial Distribution

  • 00643169315822 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

Quantum - 05060434422149

Centrifugal Hand Crank for use with CP37
SPECTRUM MEDICAL LIMITED
52-000028-00
In Commercial Distribution

  • 05060434422149 ()
52-000028-00

  • Cardiopulmonary bypass system centrifugal pump drive unit

Quantum - 05060434422132

Centrifugal Hand Crank for use with CP22
SPECTRUM MEDICAL LIMITED
52-000027-00
In Commercial Distribution

  • 05060434422132 ()
52-000027-00

  • Cardiopulmonary bypass system centrifugal pump drive unit

Quantum - 05060434421838

Quantum Centrifugal Drive High Pressure
SPECTRUM MEDICAL LIMITED
QCD37
In Commercial Distribution

  • 05060434421838 ()
51-000062-00

  • Cardiopulmonary bypass system centrifugal pump drive unit

Quantum - 05060434421821

Quantum Centrifugal Drive Medium Pressure
SPECTRUM MEDICAL LIMITED
QCD22
In Commercial Distribution

  • 05060434421821 ()
51-000061-00

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 04897102200065

Backup Battery Module
Asia Pacific Medical Technology Development Company Limited
SG1000-BBM-001
In Commercial Distribution

  • 04897102200065 ()
SG1000-BBM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit

Bio-Console® - 00613994450463

CONSOLE 560BCS1 CONTROLLER W/SAFETY BRD
MEDTRONIC, INC.
560BCS1
In Commercial Distribution

  • 00613994450463 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

Bio-Console® - 00613994450456

CONSOLE E560BCS1 EVAL CONTROLLER
MEDTRONIC, INC.
E560BCS1
In Commercial Distribution

  • 00613994450456 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

Bio-Console® - 00613994450326

CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD
MEDTRONIC, INC.
560BC1
In Commercial Distribution

  • 00613994450326 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

Bio-Console® - 00613994450319

CONSOLE R560BCS1 REFURB CONTROLLER
MEDTRONIC, INC.
R560BCS1
In Commercial Distribution

  • 00613994450319 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994115799

MOTOR 95120-008 EX DR EN FR DE IT NL
MEDTRONIC, INC.
95120-008
In Commercial Distribution

  • 00613994115799 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994258113

SENSOR LS100 LEVEL DETECTOR
MEDTRONIC, INC.
LS100
Not in Commercial Distribution

  • 00613994258113 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994258106

TAPE LST LEVEL DETECTOR MOUNT
MEDTRONIC, INC.
LST
In Commercial Distribution

  • 00613994258106 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994647832

MOTOR 560A EXTERNAL DRIVE
MEDTRONIC, INC.
560A
In Commercial Distribution

  • 00613994647832 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

AFFINITY® NT - 00613994375667

RESERVOIR 61399409462 AFFINITY 540 4PK
MEDTRONIC, INC.
61399409462
In Commercial Distribution

  • 20613994375661 ()
  • 00613994375667 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994757616

SENSOR LS100 LEVEL DETECTOR LOW PROF 12L
MEDTRONIC, INC.
LS100
In Commercial Distribution

  • 00613994757616 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994776655

MOTOR R560A EXTERNAL DRIVE SHORT
MEDTRONIC, INC.
R560A
In Commercial Distribution

  • 00613994776655 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994776648

MOTOR E560A EXTERNAL DRIVE SHORT
MEDTRONIC, INC.
E560A
In Commercial Distribution

  • 00613994776648 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994776631

MOTOR 560A EXTERNAL DRIVE SHORT
MEDTRONIC, INC.
560A
In Commercial Distribution

  • 00613994776631 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00613994776617

MOTOR R560A EXTERNAL DRIVE LONG
MEDTRONIC, INC.
R560A
In Commercial Distribution

  • 00613994776617 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit
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