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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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System M ® - 05060434420022

Extracorporeal Blood Parameter Monitor
SPECTRUM MEDICAL LIMITED
M2
Not in Commercial Distribution

  • 05060434420022 ()
3005-001-110

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434420008

Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution

  • 05060434420008 ()
51-000001-00

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 10886799001872

CDI OneView™ Calibration Gas 2
Terumo Cardiovascular Systems Corporation
CDI747
In Commercial Distribution

  • 10886799001872 ()
CDI747

  • Cardiopulmonary bypass system blood tubing set

CDI OneView™ Monitoring System - 10886799001865

CDI OneView™ Calibration Gas 1
Terumo Cardiovascular Systems Corporation
CDI746
In Commercial Distribution

  • 10886799001865 ()
CDI746

  • Cardiopulmonary bypass system blood tubing set

ECG Cables and Leadsets - 20884838006793

Preattached leadwire electrode, Square Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/Cl sensor, 3/pouch, 300/case.
Philips Medical Systems Hsg
Preattached leadwire electrode, Square
In Commercial Distribution

  • 20884838006793 ()
  • 10884838006796 ()
989803100551

  • Electrocardiographic electrode, single-use

ECG Cables and Leadsets - 20884838006762

Preattached Leadwire electrode, Medium Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket rectangular 33cm x 22cm cloth backingwith Ag/AgCl sensor, 3/pouch, 300/case.
Philips Medical Systems Hsg
Preattached Leadwire electrode, Medium
In Commercial Distribution

  • 20884838006762 ()
  • 10884838006765 ()
989803100511

  • Electrocardiographic electrode, single-use

CDI OneView™ Monitoring System - 00886799002049

CDI OneView™ Touchscreen Display
Terumo Cardiovascular Systems Corporation
CDI751
In Commercial Distribution

  • 00886799002049 ()
CDI751

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799002032

CDI OneView™ Core
Terumo Cardiovascular Systems Corporation
CDI750
In Commercial Distribution

  • 00886799002032 ()
CDI750

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799002025

Calibrator Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI783
In Commercial Distribution

  • 00886799002025 ()
CDI783

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799002018

BPM Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI782
In Commercial Distribution

  • 00886799002018 ()
CDI782

  • Portable active medical device mount
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