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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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GI Holter System - 90815187020429

M3R Intermittent and Continuous ECG Recorder
GLOBAL INSTRUMENTATION, LLC
M3R R
In Commercial Distribution

  • 90815187020429 ()
001-400-0152

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020399

M12A Enterprise System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020399 ()
005-400-0068

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020382

M12A Office System Software
GLOBAL INSTRUMENTATION, LLC
M12A
In Commercial Distribution

  • 90815187020382 ()
005-400-0067

  • Electrocardiographic ambulatory recorder

GI Holter System - 90815187020375

M3R Holter Recorder
GLOBAL INSTRUMENTATION, LLC
M3R
In Commercial Distribution

  • 90815187020375 ()
001-400-0099

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020351

5 Lead Patient Cable, IEC, M3R
GLOBAL INSTRUMENTATION, LLC
001-400-0150
In Commercial Distribution

  • 90815187020351 ()
001-400-0150

  • Electrocardiographic ambulatory recorder

Battery Cover - 90815187020344

HR100 Battery Cover
GLOBAL INSTRUMENTATION, LLC
004-200-0047
In Commercial Distribution

  • 90815187020344 ()
705673

  • Electrocardiographic ambulatory recorder

Battery Cover - 90815187020337

HR300/M3R/M12R Battery Cover
GLOBAL INSTRUMENTATION, LLC
001-200-0048
In Commercial Distribution

  • 90815187020337 ()
705674

  • Electrocardiographic ambulatory recorder

Pouch - 90815187020320

HR300/HR1200/M3R/M12R Carrying Case and Strap
GLOBAL INSTRUMENTATION, LLC
001-400-0027
In Commercial Distribution

  • 90815187020320 ()
704554

  • Electrocardiographic ambulatory recorder

Pouch - 90815187020313

HR100 Carrying Case and Strap
GLOBAL INSTRUMENTATION, LLC
004-400-0029
In Commercial Distribution

  • 90815187020313 ()
704553

  • Electrocardiographic ambulatory recorder

WA Holter System - 90815187020290

HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder
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