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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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Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system
pH Calibration Buffer Tube
DIVERSATEK HEALTHCARE, INC.
L89-6021-40
In Commercial Distribution

  • 00816734021989 ()
  • B019L896021400 ()
L89-6021-40

  • Manometric gastrointestinal motility analysis system
pH Calibration Tubes (Set of 3)
DIVERSATEK HEALTHCARE, INC.
L89-6020-40
In Commercial Distribution

  • 00816734021972 ()
  • B019L896020400 ()
L89-6020-40

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

  • 00816734021965 ()
  • B019H12R45000 ()
H12R-4500

  • Manometric gastrointestinal motility analysis system
inSight Ultima® EMG Adaptor
DIVERSATEK HEALTHCARE, INC.
H12R-4300
In Commercial Distribution

  • 00816734021958 ()
  • B019H12R43000 ()
H12R-4300

  • Manometric gastrointestinal motility analysis system
InSight Ultima® Central Unit
DIVERSATEK HEALTHCARE, INC.
H12R-2000
In Commercial Distribution

  • 00816734021941 ()
  • B019H12R20000 ()
H12R-2000

  • Manometric gastrointestinal motility analysis system
EFT Viscous Solution
DIVERSATEK HEALTHCARE, INC.
EFTV-12V
In Commercial Distribution

  • 00816734021934 ()
  • B019EFTV12V1 ()
EFTV-12V

  • Manometric gastrointestinal motility analysis system
Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 250ml
DIVERSATEK HEALTHCARE, INC.
D82-3183
In Commercial Distribution

  • 00816734021927 ()
  • B019D8231830 ()
D82-3183

  • Manometric gastrointestinal motility analysis system
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