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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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Ivenix Infusion System - 00811050530375

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
Not in Commercial Distribution

  • 00811050530375 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030467

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-08
In Commercial Distribution

  • 00811505030467 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030436

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-07
In Commercial Distribution

  • 00811505030436 ()
LVP-SW

  • Bedside infusion pump, single-channel

Ivenix Infusion System - 00811505030375

Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
In Commercial Distribution

  • 00811505030375 ()
LVP-SW

  • Bedside infusion pump, single-channel

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/W Dongle Only, 12 CH ECG - 00817980020221

ARCS Analysis & Reporting Software Dongle Only, 12 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020221 ()
A10-0118-12

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USB - 00817980020177

ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020177 ()
A10-0118-00

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG - 00817980020139

CB Series Analysis & Reporting Software - 3 & 12 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020139 ()
A10-0031

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/w & Dongle, 12 CH ECG, USB - 00817980020214

ARCS Analysis & Reporting Software & Dongle, 12 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020214 ()
A10-0118-10

  • Electrocardiographic long-term ambulatory recording analyser application software
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