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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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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
Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 250ml
DIVERSATEK HEALTHCARE, INC.
D82-3182
In Commercial Distribution

  • 00816734021910 ()
  • B019D8231820 ()
D82-3182

  • Manometric gastrointestinal motility analysis system
Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 250ml
DIVERSATEK HEALTHCARE, INC.
D82-3181
In Commercial Distribution

  • 00816734021903 ()
  • B019D8231810 ()
D82-3181

  • Manometric gastrointestinal motility analysis system
Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3152
In Commercial Distribution

  • 00816734021897 ()
  • B019D8231520 ()
D82-3152

  • Manometric gastrointestinal motility analysis system
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