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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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H12+ - 00812345021653

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BAA-XXXXX
Not in Commercial Distribution

  • 00812345021653 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021646

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AAA-XXXXX
Not in Commercial Distribution

  • 00812345021646 ()


  • Electrocardiographic ambulatory recorder

medilogAR U - 07613365003765

The medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution

  • 07613365003765 ()
  • 07613365003697 ()
1A.306010

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020719

M12R L Recorder, 10-Lead Cable, AHA, System Kit 90815187020184; M12R, 10 Lead patient Cable (DIN) 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
GLOBAL INSTRUMENTATION, LLC
001-400-0123
In Commercial Distribution

  • 90815187020719 ()
001-400-0123

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020702

M12R Recorder, 7-Lead Cable AHA, System Kit 90815187020153; M12R, 7 Lead patient Cable (AHA) 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
GLOBAL INSTRUMENTATION, LLC
001-400-0105
In Commercial Distribution

  • 90815187020702 ()
001-400-0105

  • Electrocardiographic ambulatory recorder

Matrix Holter System - 90815187020696

M12R Recorder, 10-Lead Cable AHA, System Kit 90815187020191; M12R, 10 Lead Patient Cable 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
GLOBAL INSTRUMENTATION, LLC
001-400-0107
In Commercial Distribution

  • 90815187020696 ()
001-400-0107

  • Electrocardiographic ambulatory recorder

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
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