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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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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

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 - B019H12R4500300

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

  • B019H12R4500300 ()
H12R-4500-30

  • Manometric gastrointestinal motility analysis system

SICAT Air - B06965436510

No Description
HiCat GmbH
6543651
In Commercial Distribution

  • B06965436510 ()


  • Diagnostic x-ray digital imaging system workstation

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
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