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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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MiVu - 00816734022719

MiVu Mucosal Integrity Regulator
DIVERSATEK HEALTHCARE, INC.
MI-REG-01
In Commercial Distribution

  • 00816734022719 ()
MI-REG-01

  • Manometric gastrointestinal motility analysis system

Zvu - 00816734022429

Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system

M12 System - 00815187020754

SD Card (GI Label)
GLOBAL INSTRUMENTATION, LLC
000-400-0129
In Commercial Distribution

  • 00815187020754 ()
000-400-0129

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020600

M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0195
In Commercial Distribution

  • 00815187020600 ()
009-400-0195

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020594

M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5 3-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0194
In Commercial Distribution

  • 00815187020594 ()
009-400-0194

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020587

M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0193
In Commercial Distribution

  • 00815187020587 ()
009-400-0193

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020570

M5 Neck Lanyard
GLOBAL INSTRUMENTATION, LLC
009-400-0205
In Commercial Distribution

  • 00815187020570 ()
009-400-0205

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020563

M5 Recorder, USB Cable, USB Wall Charger, System Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0192
In Commercial Distribution

  • 00815187020563 ()
009-400-0192

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020556

M5 Recorder
GLOBAL INSTRUMENTATION, LLC
M5
In Commercial Distribution

  • 00815187020556 ()
009-400-0180

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020549

M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0178
In Commercial Distribution

  • 00815187020549 ()
009-400-0178

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020471

M5 4-Lead Patient Cable - RL Lead AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0171
In Commercial Distribution

  • 00815187020471 ()
009-400-0171

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020457

M5 3-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0169
In Commercial Distribution

  • 00815187020457 ()
009-400-0169

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020440

M5 2-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0168
In Commercial Distribution

  • 00815187020440 ()
009-400-0168

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020433

M5 Patch Electrode, 2-Lead
GLOBAL INSTRUMENTATION, LLC
009-400-0167
In Commercial Distribution

  • 00815187020433 ()
009-400-0167

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020112

M5 Patient Cable Cradle
GLOBAL INSTRUMENTATION, LLC
009-400-0206
In Commercial Distribution

  • 00815187020112 ()
009-400-0206

  • Electrocardiographic ambulatory recorder

Nuubo System - 08437011759078

NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.
SMART SOLUTIONS TECHNOLOGIES SL
2140
In Commercial Distribution

  • 08437011759078 ()
2140

  • Electrocardiographic ambulatory recorder

Blue2 4th Generation - 00186648000609

No Description
Ablenet, Inc.
10000033
In Commercial Distribution

  • 00186648000609 ()
10000033

  • Assistive human interface device proximal control, hand-operated

Vasomedical-Biox™ Model 1308 12 CH ULTRA Recorder w/Bluetooth - 00817980020450

Model 1308 12 CH ULTRA Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 1308 Kit
In Commercial Distribution

  • 00817980020450 ()
A10-1308-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder - 00817980020443

Model 1307 3 CH ULTRA Recorder
VASOMEDICAL, INC.
Model 1307 Kit
In Commercial Distribution

  • 00817980020443 ()
A10-1307-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient Cable - 00817980020436

Model 1306 12 CH Recorder - 10 Lead Patient Cable
VASOMEDICAL, INC.
Model 1306 Kit
In Commercial Distribution

  • 00817980020436 ()
A10-1306-01-04-02

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1305 3 CH Recorder - 7 Lead Patient Cable - 00817980020429

Model 1305 3 CH Recorder - 7 Lead Patient Cable
VASOMEDICAL, INC.
Model 1305 Kit
In Commercial Distribution

  • 00817980020429 ()
A10-1305-01-04-03

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1305 3 CH Recorder - 5 Lead Patient Cable - 00817980020412

Model 1305 3 CH Recorder - 5 Lead Patient Cable
VASOMEDICAL, INC.
Model 1305 Kit
In Commercial Distribution

  • 00817980020412 ()
A10-1305-01-04-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1304 12 CH Recorder - 10 Lead Patient Cable - 00817980020405

Model 1304 12 CH Recorder - 10 Lead Patient Cable
VASOMEDICAL, INC.
Model 1304 Kit
In Commercial Distribution

  • 00817980020405 ()
A10-1304-01-04-02

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable - 00817980020399

Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable
VASOMEDICAL, INC.
Model 1303 Kit
In Commercial Distribution

  • 00817980020399 ()
A10-1303-01-04-02

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient Cable - 00817980020382

Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient Cable
VASOMEDICAL, INC.
Model 1303 Kit
In Commercial Distribution

  • 00817980020382 ()
A10-1303-01-04-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1201 3 CH Mini ECG Recorder - 00817980020375

Model 1201 3 CH Mini ECG Recorder
VASOMEDICAL, INC.
Model 1201 Kit
In Commercial Distribution

  • 00817980020375 ()
A10-1201-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1200 2 CH Mini ECG Recorder - 00817980020368

Model 1200 2 CH Mini ECG Recorder
VASOMEDICAL, INC.
Model 1200 Kit
In Commercial Distribution

  • 00817980020368 ()
A10-1200-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1201 ECG Holter Mini Recorder - 00817980020351

1201 ECG Holter Mini Recorder
VASOMEDICAL, INC.
Model 1201
In Commercial Distribution

  • 00817980020351 ()
A10-1201-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1200 ECG Holter Mini Recorder - 00817980020344

1200 ECG Holter Mini Recorder
VASOMEDICAL, INC.
Model 1200
In Commercial Distribution

  • 00817980020344 ()
A10-1200-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1303 Ultra Compact 3 Channel ECG Holter Recorder - 00817980020191

3 CH ECG Holter ULTRA Recorder
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020191 ()
A10-0087

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020184

12 CH ECG Holter ULTRA Recorder
VASOMEDICAL, INC.
Model 1306
In Commercial Distribution

  • 00817980020184 ()
A10-1306-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth - 00817980020122

12 CH ECG Holter/ABP COMB Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 2306
In Commercial Distribution

  • 00817980020122 ()
A10-2306-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with Bluetooth - 00817980020115

3 CH ECG Holter/ABP COMB Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 2305
In Commercial Distribution

  • 00817980020115 ()
A10-2305-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2304 Combined 12 Channel ECG Holter & ABP Monitor - 00817980020108

12 CH ECG Holter/ABP COMB Recorder
VASOMEDICAL, INC.
Model 2304
In Commercial Distribution

  • 00817980020108 ()
A10-2304-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020092

3 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2303
In Commercial Distribution

  • 00817980020092 ()
A10-2303-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2302 Combined 12 Channel ECG Holter & ABP Monitor - 00817980020085

12 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2302
In Commercial Distribution

  • 00817980020085 ()
A10-0086

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020078

3 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2301
In Commercial Distribution

  • 00817980020078 ()
A10-0085

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020030

12 CH ECG Holter Ultra Recorder
VASOMEDICAL, INC.
Model 1308
In Commercial Distribution

  • 00817980020030 ()
A10-1308-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder - 00817980020023

12 CH ECG Holter Recorder
VASOMEDICAL, INC.
Model 1304
In Commercial Distribution

  • 00817980020023 ()
A10-0082

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder - 00817980020016

3 CH ECG Holter ULTRA Recorder
VASOMEDICAL, INC.
Model 1307
In Commercial Distribution

  • 00817980020016 ()
A10-1307-01

  • Electrocardiographic ambulatory recorder
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