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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 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 - 00817655021102

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AA-AAXXA
Not in Commercial Distribution

  • 00817655021102 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021096

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AB-AXXXC
Not in Commercial Distribution

  • 00817655021096 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655021089

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AB-AXXXB
Not in Commercial Distribution

  • 00817655021089 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655020570

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AA-AXXXA
Not in Commercial Distribution

  • 00817655020570 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655020563

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6BA-XXXXX
In Commercial Distribution

  • 00817655020563 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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