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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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Vision Express - 00812345027082

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-5
In Commercial Distribution

  • 00812345027082 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Vision Express - 00812345027075

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-2
In Commercial Distribution

  • 00812345027075 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Vision Express - 00812345027068

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-1
In Commercial Distribution

  • 00812345027068 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Vision Express - 00812345027051

Holter Analysis System
MORTARA INSTRUMENT, INC.
BURV53H-0
In Commercial Distribution

  • 00812345027051 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

medilog DARWIN2 U - 07613365003758

The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders.
Schiller AG
0.282200
In Commercial Distribution

  • 07613365003758 ()
0.282200

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W Dongle - Mini 1200/1201 2 & 3 CH ECG - 00817980020337

ARCS Analysis & Reporting Software Dongle - Mini 1200/1201 2 & 3 CH ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020337 ()
A10-0122-02

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200 / 1201, 2 & 3 CH ECG - 00817980020313

ARCS Analysis & Reporting S/W & Dongle- Mini 1200 / 1201, 2 & 3 CH ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020313 ()
A10-0122-00

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP),USB w/Bluetooth - 00817980020306

ARCS S/W & Dongle, Comb (3 CH ECG & ABP), USB w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020306 ()
A10-0118-70

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB w/Bluetooth - 00817980020276

ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020276 ()
A10-0118-40

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W Dongle Only (12 CH ECG & ABP) - 00817980020269

ARCS Analysis & Reporting S/W Dongle Only, Comb (12 CH ECG & ABP)
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020269 ()
A10-0118-32

  • Electrocardiographic long-term ambulatory recording analyser application software
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