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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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Vasomedical-Biox™ ARCS Analysis & Reporting Software Dongle Only, 3 CH ECG - 00817980020207

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

  • 00817980020207 ()
A10-0118-02

  • 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 S/w - 3 & 12 CH ECG & ABP - 00817980020160

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

  • 00817980020160 ()
A10-0036

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG & ABP - 00817980020153

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

  • 00817980020153 ()
A10-0035

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG - 00817980020146

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

  • 00817980020146 ()
A10-0032

  • 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

HScribe - 00812345029857

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6AA-XXXXA
In Commercial Distribution

  • 00812345029857 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345029840

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-YXXXC
In Commercial Distribution

  • 00812345029840 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345029826

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBEWS-6AC-YXXXX
In Commercial Distribution

  • 00812345029826 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027334

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-XXXXX
In Commercial Distribution

  • 00812345027334 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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