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

  • 90815187020177 ()
001-400-0002

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

  • 90815187020160 ()
001-400-0004

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

  • 90815187020153 ()
001-400-0018

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

  • 90815187020146 ()
704550

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

  • 90815187020139 ()
704549

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

  • 90815187020122 ()
711059

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

  • B019ULT1HD0 ()
ULT1-H-D

  • Manometric gastrointestinal motility analysis system
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® HRaM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HA-D
In Commercial Distribution

  • B019ULT1HAD0 ()
ULT1-HA-D

  • Manometric gastrointestinal motility analysis system
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® 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® System No Workstation
DIVERSATEK HEALTHCARE, INC.
ULT1-S-I
In Commercial Distribution

  • B019ULT1SI0 ()
ULT1-S-I

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® Base System
DIVERSATEK HEALTHCARE, INC.
ULT1-S
In Commercial Distribution

  • B019ULT1S0 ()
ULT1-S

  • Manometric gastrointestinal motility analysis system
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® HRiM SD System
DIVERSATEK HEALTHCARE, INC.
ULT1-HSD-D
In Commercial Distribution

  • B019ULT1HSDD0 ()
ULT1-HSD-D

  • Manometric gastrointestinal motility analysis system
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® HRM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HP-D
In Commercial Distribution

  • B019ULT1HPD0 ()
ULT1-HP-D

  • Manometric gastrointestinal motility analysis system
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® HRCA System, Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HCA-D
In Commercial Distribution

  • B019ULT1HCAD0 ()
ULT1-HCA-D

  • Manometric gastrointestinal motility analysis system
inSIGHT Legacy Adaptor Cable
DIVERSATEK HEALTHCARE, INC.
H12R-4500-30
In Commercial Distribution

  • B019H12R4500300 ()
H12R-4500-30

  • Manometric gastrointestinal motility analysis system
No Description
BRAEMAR MANUFACTURING, LLC
100-0046-02
In Commercial Distribution

  • B146M10 ()


  • Electrocardiographic ambulatory recorder
No Description
BRAEMAR MANUFACTURING, LLC
900-0612-04
In Commercial Distribution

  • B146ERWCD040 ()


  • Electrocardiographic ambulatory recorder
No Description
BRAEMAR MANUFACTURING, LLC
900-0570-25
In Commercial Distribution

  • B146DL9ZW0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-11
In Commercial Distribution

  • B146DL8CL0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-19
In Commercial Distribution

  • B146DL8BD0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-04
In Commercial Distribution

  • B146DL8B1330 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-09
In Commercial Distribution

  • B146DL8256B0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
100-0030-01
In Commercial Distribution

  • B146CK0 ()


  • Electrocardiographic ambulatory recorder
MCOT Holter
BRAEMAR MANUFACTURING, LLC
900-0634-00
In Commercial Distribution

  • B146C6S0 ()


  • Electrocardiographic ambulatory recorder
No Description
BRAEMAR MANUFACTURING, LLC
02-02124
In Commercial Distribution

  • B146C6R30 ()


  • Electrocardiographic ambulatory recorder
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