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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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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

NA - 00673978170114

MOTOR R95120-03 EXT DRIVE RECOND 540T
MEDTRONIC, INC.
R95120-03
In Commercial Distribution

  • 00673978170114 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00673978169675

MOTOR E95120-03 EXT DRIVE EVAL 540T 5L
MEDTRONIC, INC.
E95120-03
In Commercial Distribution

  • 00673978169675 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

NA - 00673978166025

MOTOR 95120-005 BIOCONSOLE 3L 540T EDM
MEDTRONIC, INC.
95120-005
Not in Commercial Distribution

  • 00673978166025 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

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

BIOCONSOLE® - 00673978877235

CONSOLE R95208 RCOND BIO-CONS550 W/O DIG
MEDTRONIC, INC.
R95208
In Commercial Distribution

  • 00673978877235 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit

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

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

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 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 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 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
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