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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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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

HScribe - 00812345027280

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSREV-AAA-BXXAA
Not in Commercial Distribution

  • 00812345027280 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027273

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-XXXXB
In Commercial Distribution

  • 00812345027273 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027266

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXX
In Commercial Distribution

  • 00812345027266 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027259

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AB-YXXXB
Not in Commercial Distribution

  • 00812345027259 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027242

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AB-AXXXD
Not in Commercial Distribution

  • 00812345027242 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027235

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-YXXXD
Not in Commercial Distribution

  • 00812345027235 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027228

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXC
Not in Commercial Distribution

  • 00812345027228 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027211

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXB
In Commercial Distribution

  • 00812345027211 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027204

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AC-AXXXA
Not in Commercial Distribution

  • 00812345027204 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027198

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AB-AXXXB
In Commercial Distribution

  • 00812345027198 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027181

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AXXXX
Not in Commercial Distribution

  • 00812345027181 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027174

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AXXXC
Not in Commercial Distribution

  • 00812345027174 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027167

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AXXXB
Not in Commercial Distribution

  • 00812345027167 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027150

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXX
Not in Commercial Distribution

  • 00812345027150 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027143

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXC
Not in Commercial Distribution

  • 00812345027143 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027136

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXB
Not in Commercial Distribution

  • 00812345027136 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027129

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-5AA-AAXXA
Not in Commercial Distribution

  • 00812345027129 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C4MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-08
In Commercial Distribution

  • B146C4MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C4MA020

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-02
In Commercial Distribution

  • B146C4MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C4MA000

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-00
In Commercial Distribution

  • B146C4MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-08
In Commercial Distribution

  • B146C3MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA070

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-07
In Commercial Distribution

  • B146C3MA070 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA050

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-05
In Commercial Distribution

  • B146C3MA050 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA020

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-02
In Commercial Distribution

  • B146C3MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA00

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-00
In Commercial Distribution

  • B146C3MA00 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C2MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0619-08
In Commercial Distribution

  • B146C2MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C2MA000

No Description
BRAEMAR MANUFACTURING, LLC
900-0619-00
In Commercial Distribution

  • B146C2MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0618-08
In Commercial Distribution

  • B146C1MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA070

No Description
BRAEMAR MANUFACTURING, LLC
900-0618-07
In Commercial Distribution

  • B146C1MA070 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA051010

The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-05
In Commercial Distribution

  • B146C1MA051010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA041010

The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-04
In Commercial Distribution

  • B146C1MA041010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

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 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, USB - 00817980020320

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

  • 00817980020320 ()
A10-0122-01

  • 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 ABP Analysis & Reporting S/W & Dongle w/Bluetooth - 00817980020290

ARCS ABP Analysis & Reporting Software & Dongle w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020290 ()
A10-0118-60

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle - 00817980020283

ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • 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

Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP),USB - 00817980020252

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

  • 00817980020252 ()
A10-0118-30

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W Dongle Only (3 CH ECG & ABP) - 00817980020245

ARCS Analysis & Reporting S/W Dongle Only, Comb (3 CH ECG & ABP)
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020245 ()
A10-0118-22

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP), USB - 00817980020238

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

  • 00817980020238 ()
A10-0118-20

  • 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, 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

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
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