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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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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

Bio30+ Sys Physio HP EZ Nin - 05056336800239

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software
BIOCHROM LIMITED
80-6000-53EZ
In Commercial Distribution

  • 05056336800239 ()


  • Amino acid analyser IVD

Waste Transfer Set - 04052682031724

For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2172
In Commercial Distribution

  • 04052682031724 ()
  • 14052682031721 ()
X6C2172

  • Blood transfer set

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937678

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8224
In Commercial Distribution

  • 04710961937678 ()
  • 14710961937675 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937661

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8222
In Commercial Distribution

  • 04710961937661 ()
  • 14710961937668 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937654

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8220
In Commercial Distribution

  • 04710961937654 ()
  • 14710961937651 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937647

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8218
In Commercial Distribution

  • 04710961937647 ()
  • 14710961937644 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937630

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8216
In Commercial Distribution

  • 04710961937630 ()
  • 14710961937637 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937623

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8214
In Commercial Distribution

  • 04710961937623 ()
  • 14710961937620 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937616

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8212
In Commercial Distribution

  • 04710961937616 ()
  • 14710961937613 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934257

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8224
In Commercial Distribution

  • 04710961934257 ()
  • 14710961934254 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934240

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8222
In Commercial Distribution

  • 04710961934240 ()
  • 14710961934247 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934233

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8220
In Commercial Distribution

  • 04710961934233 ()
  • 14710961934230 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934226

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8218
In Commercial Distribution

  • 04710961934226 ()
  • 14710961934223 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934219

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8216
In Commercial Distribution

  • 04710961934219 ()
  • 14710961934216 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934202

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8214
In Commercial Distribution

  • 04710961934202 ()
  • 14710961934209 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934196

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8212
In Commercial Distribution

  • 04710961934196 ()
  • 14710961934193 ()


  • Suprapubic drainage catheter

Source Exchange Tube for Container T41, Ir-192 - 04049223106058

No Description
Eckert & Ziegler BEBIG GmbH
LAZ20-04
Not in Commercial Distribution

  • 04049223106058 ()
LAZ20-04

  • Brachytherapy system remote afterloading source safe

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

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 - 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 - 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 - 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

NA - 00613994776594

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

  • 00613994776594 ()


  • 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 - 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

Anivia SG1000 Pump Console - 00850000067134

Level Sensor Module
APMTD, Inc.
SG1000-LSM-001
In Commercial Distribution

  • 00850000067134 ()
SG1000-LSM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067127

Cart
APMTD, Inc.
SG1000-CRT-001
In Commercial Distribution

  • 00850000067127 ()
SG1000-CRT-001

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067110

Flow Bubble Sensor
APMTD, Inc.
SG1000-FBS-002
In Commercial Distribution

  • 00850000067110 ()
SG1000-FBS-002

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067103

Flow Bubble Sensor
APMTD, Inc.
SG1000-FBS-001
In Commercial Distribution

  • 00850000067103 ()
SG1000-FBS-001

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067097

Pump Driver Module
APMTD, Inc.
SG1000-PDM-004
In Commercial Distribution

  • 00850000067097 ()
SG1000-PDM-004

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067080

Pump Driver Module
APMTD, Inc.
SG1000-PDM-003
In Commercial Distribution

  • 00850000067080 ()
SG1000-PDM-003

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067073

Pump Driver Module
APMTD, Inc.
SG1000-PDM-002
In Commercial Distribution

  • 00850000067073 ()
SG1000-PDM-002

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067066

Pump Driver Module
APMTD, Inc.
SG1000-PDM-001
In Commercial Distribution

  • 00850000067066 ()
SG1000-PDM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067059

Display and Control Module
APMTD, Inc.
SG1000-DCM-001
In Commercial Distribution

  • 00850000067059 ()
SG1000-DCM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit
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