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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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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 - 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

SICAT Air - B06965436510

No Description
HiCat GmbH
6543651
In Commercial Distribution

  • B06965436510 ()


  • Diagnostic x-ray digital imaging system workstation

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 - 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 - 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 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
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