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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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SURGICOUNT - 07613327568981

+ EMR/QBL APPLICATION
STRYKER CORPORATION
0694-002-100
In Commercial Distribution

  • 07613327568981 ()
0694-002-100

  • Electronic surgical sponge-counter

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

H12+ - 00812345021660

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

  • 00812345021660 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021646

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

  • 00812345021646 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345021684

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-AAA-XXXXX
In Commercial Distribution

  • 00812345021684 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021653

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

  • 00812345021653 ()


  • 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

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

WA Holter System - 90815187020283

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

  • 90815187020283 ()
402811

  • Electrocardiographic ambulatory recorder

WA Holter System - 90815187020276

HR100 Holter Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR100
In Commercial Distribution

  • 90815187020276 ()
402810

  • Electrocardiographic ambulatory recorder

GI Holter System - 90815187020269

M12R L Holter Recorder
GLOBAL INSTRUMENTATION, LLC
M12R
In Commercial Distribution

  • 90815187020269 ()
001-400-0122

  • Electrocardiographic ambulatory recorder

GI Holter System - 90815187020252

M12R Holter Recorder
GLOBAL INSTRUMENTATION, LLC
M12R
In Commercial Distribution

  • 90815187020252 ()
001-400-0064

  • Electrocardiographic ambulatory recorder

GI Holter System - 90815187020245

M3R L Holter Recorder
GLOBAL INSTRUMENTATION, LLC
M3R
In Commercial Distribution

  • 90815187020245 ()
004-400-0153

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020238

7 Lead Patient Cable, IEC, HR100
GLOBAL INSTRUMENTATION, LLC
004-400-0021
In Commercial Distribution

  • 90815187020238 ()
704548

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020221

7 Lead Patient Cable, AHA, HR100
GLOBAL INSTRUMENTATION, LLC
004-400-0006
In Commercial Distribution

  • 90815187020221 ()
704547

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020214

5-Lead Patient Cable, IEC
GLOBAL INSTRUMENTATION, LLC
004-400-0022
In Commercial Distribution

  • 90815187020214 ()
004-400-0022

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020207

5-Lead Patient Cable, AHA, HR100
GLOBAL INSTRUMENTATION, LLC
004-400-0008
In Commercial Distribution

  • 90815187020207 ()
704545

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020191

M12R, 10 Lead Patient Cable
GLOBAL INSTRUMENTATION, LLC
001-400-0120
In Commercial Distribution

  • 90815187020191 ()
001-400-0120

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020184

M12R, 10 Lead patient Cable (DIN)
GLOBAL INSTRUMENTATION, LLC
001-400-0020
In Commercial Distribution

  • 90815187020184 ()
001-400-0020

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020177

M12R, 10 Lead patient Cable (AHA)
GLOBAL INSTRUMENTATION, LLC
001-400-0002
In Commercial Distribution

  • 90815187020177 ()
001-400-0002

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020160

M3R/M12R, 7 Lead patient Cable
GLOBAL INSTRUMENTATION, LLC
001-400-0004
In Commercial Distribution

  • 90815187020160 ()
001-400-0004

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020153

M3R/M12R, 7 Lead patient Cable (AHA)
GLOBAL INSTRUMENTATION, LLC
001-400-0018
In Commercial Distribution

  • 90815187020153 ()
001-400-0018

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020146

7 Lead Patient Cable, IEC, HR300
GLOBAL INSTRUMENTATION, LLC
001-400-0028
In Commercial Distribution

  • 90815187020146 ()
704550

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020139

7 Lead Patient Cable, AHA, HR300
GLOBAL INSTRUMENTATION, LLC
001-400-0017
In Commercial Distribution

  • 90815187020139 ()
704549

  • Electrocardiographic ambulatory recorder

Patient Cable - 90815187020122

5 Lead Patient Cable, IEC, HR300
GLOBAL INSTRUMENTATION, LLC
001-400-0095
In Commercial Distribution

  • 90815187020122 ()
711059

  • Electrocardiographic ambulatory recorder

inSIGHT Ultima - B019ULT1HD0

InSIGHT Ultima® HRiM2 System
DIVERSATEK HEALTHCARE, INC.
ULT1-H-D
In Commercial Distribution

  • B019ULT1HD0 ()
ULT1-H-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HAI0

inSIGHT Ultima® HRaM System, Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HA-I
In Commercial Distribution

  • B019ULT1HAI0 ()
ULT1-HA-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HAD0

InSIGHT Ultima® HRaM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HA-D
In Commercial Distribution

  • B019ULT1HAD0 ()
ULT1-HA-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1CIED0

inSIGHT Ultima® Air-Charged Manometry System
DIVERSATEK HEALTHCARE, INC.
ULT1-CIE-D
In Commercial Distribution

  • B019ULT1CIED0 ()
ULT1-CIE-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1SIA0

inSIGHT Ultima® System No Workstation No Monitor Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-S-IA
In Commercial Distribution

  • B019ULT1SIA0 ()
ULT1-S-IA

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1SI0

inSIGHT Ultima® System No Workstation
DIVERSATEK HEALTHCARE, INC.
ULT1-S-I
In Commercial Distribution

  • B019ULT1SI0 ()
ULT1-S-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1S0

inSIGHT Ultima® Base System
DIVERSATEK HEALTHCARE, INC.
ULT1-S
In Commercial Distribution

  • B019ULT1S0 ()
ULT1-S

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HSDI0

inSIGHT Ultima® HRiM SD System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HSD-I
In Commercial Distribution

  • B019ULT1HSDI0 ()
ULT1-HSD-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HSDD0

inSIGHT Ultima® HRiM SD System
DIVERSATEK HEALTHCARE, INC.
ULT1-HSD-D
In Commercial Distribution

  • B019ULT1HSDD0 ()
ULT1-HSD-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HPI0

inSIGHT Ultima® HRZ HRM System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HP-I
In Commercial Distribution

  • B019ULT1HPI0 ()
ULT1-HP-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HPD0

inSIGHT Ultima® HRM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HP-D
In Commercial Distribution

  • B019ULT1HPD0 ()
ULT1-HP-D

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HI0

InSIGHT Ultima® HRiM2 System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-H-I
In Commercial Distribution

  • B019ULT1HI0 ()
ULT1-H-I

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - B019ULT1HCAD0

inSIGHT Ultima® HRCA System, Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HCA-D
In Commercial Distribution

  • B019ULT1HCAD0 ()
ULT1-HCA-D

  • Manometric gastrointestinal motility analysis system

inSIGHT - B019H12R4500300

inSIGHT Legacy Adaptor Cable
DIVERSATEK HEALTHCARE, INC.
H12R-4500-30
In Commercial Distribution

  • B019H12R4500300 ()
H12R-4500-30

  • Manometric gastrointestinal motility analysis system
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