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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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Novalung System - 04057224902043

The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support.
XENIOS AG
Novalung console
In Commercial Distribution

  • 04057224902043 ()
30000162

  • 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

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 - 00613994647832

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

  • 00613994647832 ()


  • 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 - 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 - 00613994776648

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

  • 00613994776648 ()


  • 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

NA - 00613994757616

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

  • 00613994757616 ()


  • 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 - 05060434421821

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

  • 05060434421821 ()
51-000061-00

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Caddy - 10850007732353

The VitalFlow Caddy is a holder for the VitalFlow motor drive (Model 58102), VitalFlow emergency handcrank (Model 58103), and Nautilus™ VF ECMO oxygenator with Balance™ Biosurface (Model 58110).
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58120
In Commercial Distribution

  • 10850007732353 ()
58120

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Power Cord 12 V DC, 3m - 10850007732308

DC Power Cord (12 V DC, 3m) for VitalFlow Console
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58141
In Commercial Distribution

  • 10850007732308 ()
58141

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Power Cord CEE 7/7, 2.5m - 10850007732292

AC Power Cord (EU Type F, CEE 7/7, 2.5m) for VitalFlow Console
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58132
In Commercial Distribution

  • 10850007732292 ()
58132

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Power Cord NEMA-5-15, 3m - 10850007732285

AC Power Cord (US Type A, NEMA-5-15, 3m) for VitalFlow Console
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58131
In Commercial Distribution

  • 10850007732285 ()
58131

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Flow and Bubble Sensor, 2m - 10850007732278

Flow and Bubble Sensor (2m) for VitalFlow Console
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58150
In Commercial Distribution

  • 10850007732278 ()
58150

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Emergency Handcrank - 10850007732261

Emergency handcrank for the VitalFlow Centrifugal Pump
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58103
In Commercial Distribution

  • 10850007732261 ()
58103

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Motor Drive - 10850007732254

Motor drive for the VitalFlow Centrifugal Pump
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58102
In Commercial Distribution

  • 10850007732254 ()
58102

  • Cardiopulmonary bypass system centrifugal pump drive unit

VitalFlow Console - 10850007732247

Controller for VitalFlow Centrifugal Pump. The VitalFlow Console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for circuit data only; no patient data are stored or output.
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
58100
In Commercial Distribution

  • 10850007732247 ()
58100

  • Cardiopulmonary bypass system centrifugal pump drive unit

2nd Gen CentriMag Primary Console - 07640135140702

No Description
Thoratec Switzerland GmbH
201-90411
In Commercial Distribution

  • 07640135140702 ()
201-90411

  • Cardiopulmonary bypass system centrifugal pump drive unit

CENTRIMAG PRIMARY CONSOLE - 07640135140672

No Description
Thoratec Switzerland GmbH
102954
In Commercial Distribution

  • 07640135140672 ()
102954

  • Cardiopulmonary bypass system centrifugal pump drive unit

METAL LOCKING FEATURE FOR CENTRIMAG MOTOR - 07640135140405

No Description
Thoratec Switzerland GmbH
104326
In Commercial Distribution

  • 07640135140405 ()
104326

  • Cardiopulmonary bypass system centrifugal pump drive unit

CENTRIMAG MOTOR - 07640135140078

No Description
Thoratec Switzerland GmbH
102956
In Commercial Distribution

  • 07640135140078 ()
102956

  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020906

IV Pole Clamp for blood pump controller
CARDIACASSIST, INC.
5900-0012
Not in Commercial Distribution

  • 00814112020906 ()
5900-0012

  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020654

Removable Batteries of LifeSPARC blood pump controller
CARDIACASSIST, INC.
5900-0004
Not in Commercial Distribution

  • 00814112020654 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020647

Power cord for blood pump controller charging station
CARDIACASSIST, INC.
5900-0010
Not in Commercial Distribution

  • 00814112020647 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020630

Charging station for blood pump controller
CARDIACASSIST, INC.
5900-0002
Not in Commercial Distribution

  • 00814112020630 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020623

Blood pump controller
CARDIACASSIST, INC.
5900-0001
Not in Commercial Distribution

  • 00814112020623 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020586

Controller Battery
CARDIACASSIST, INC.
1000-0765
Not in Commercial Distribution

  • 00814112020586 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020579

Flow Sensor
CARDIACASSIST, INC.
5900-0003
Not in Commercial Distribution

  • 00814112020579 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

LifeSPARC - 00814112020562

Blood pump controller, charging station, Power cord, flow sensor, removable batteries
CARDIACASSIST, INC.
5900-0000
Not in Commercial Distribution

  • 00814112020562 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

INSPIRA ART100 - 07290117830116

No Description
INSPIRA TECHNOLOGIES OXY B.H.N LTD
Packed INSPIRA ART100 System
In Commercial Distribution

  • 07290117830116 ()
INS-010801P

  • Cardiopulmonary bypass system centrifugal pump drive unit

INSPIRA ART100 - 07290117830055

No Description
INSPIRA TECHNOLOGIES OXY B.H.N LTD
INSPIRA ART100 Pump Drive
In Commercial Distribution

  • 17290117830052 ()
  • 07290117830055 ()
INS-010201

  • Cardiopulmonary bypass system centrifugal pump drive unit

INSPIRA ART100 - 07290117830048

No Description
INSPIRA TECHNOLOGIES OXY B.H.N LTD
INSPIRA ART100 Controller
In Commercial Distribution

  • 07290117830048 ()
  • 17290117830045 ()
INS-010101

  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00763000244873

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

  • 00763000244873 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00763000244866

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

  • 00763000244866 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit
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