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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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Single-Use pH Probe, Infused, Dual pH (Esophageal) 5cm Spacing with LES Port
DIVERSATEK HEALTHCARE, INC.
PHI5
In Commercial Distribution

  • 00816734022023 ()
  • B019PHI50 ()

  • Catheter Gauge: 6.9 French
PHI5

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Infused, Dual pH (Esophageal) 15cm Spacing with LES Port
DIVERSATEK HEALTHCARE, INC.
PHI15
In Commercial Distribution

  • 00816734022016 ()
  • B019PHI150 ()

  • Catheter Gauge: 6.9 French
PHI15

  • Manometric gastrointestinal motility analysis system
Single-Use pH Probe, Infused, Dual pH (Esophageal) 10cm Spacing with LES Port
DIVERSATEK HEALTHCARE, INC.
PHI10
In Commercial Distribution

  • 00816734022009 ()
  • B019PHI100 ()

  • Catheter Gauge: 6.9 French
PHI10

  • 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
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
Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3151
In Commercial Distribution

  • 00816734021880 ()
  • B019D8231510 ()
D82-3151

  • Manometric gastrointestinal motility analysis system
Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3103
In Commercial Distribution

  • 00816734021873 ()
  • B019D8231030 ()
D82-3103

  • Manometric gastrointestinal motility analysis system
Motility Cart for inSIGHT Ultima® and PriZm Motility Systems
DIVERSATEK HEALTHCARE, INC.
CART5R
In Commercial Distribution

  • 00816734021866 ()
  • B019CART5R0 ()
CART5R

  • Manometric gastrointestinal motility analysis system
Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-5070
In Commercial Distribution

  • 10816734021856 ()
  • 00816734021859 ()
  • B019A8650700 ()
A86-5070

  • Manometric gastrointestinal motility analysis system
MiVu Mucosal Integrity Cable
DIVERSATEK HEALTHCARE, INC.
MI-CAB-01
In Commercial Distribution

  • 00816734021842 ()
MI-CAB-01

  • Manometric gastrointestinal motility analysis system
Anorectal Balloon, 400CC TPE
DIVERSATEK HEALTHCARE, INC.
A86-4300-10
In Commercial Distribution

  • 10816734021832 ()
  • 00816734021835 ()
  • B019A864300100 ()
A86-4300-10

  • Manometric gastrointestinal motility analysis system
Air Charged Adapter Cable
DIVERSATEK HEALTHCARE, INC.
GIS-7010
In Commercial Distribution

  • 00816734021828 ()
GIS-7010

  • Manometric gastrointestinal motility analysis system
Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-1070
In Commercial Distribution

  • 10816734021689 ()
  • 00816734021682 ()
  • B019A8610700 ()
A86-1070

  • Manometric gastrointestinal motility analysis system
Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04-2000-S
In Commercial Distribution

  • 00816734021675 ()
  • B019A042000S0 ()
A04-2000-S

  • Manometric gastrointestinal motility analysis system
Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04R-2500
In Commercial Distribution

  • 00816734021668 ()
  • B019A04R25000 ()
A04R-2500

  • Manometric gastrointestinal motility analysis system
HRaM Syringe/Stopcock Kit
DIVERSATEK HEALTHCARE, INC.
A86-4120
In Commercial Distribution

  • 00816734021545 ()
  • B019A8641200 ()
A86-4120

  • Manometric gastrointestinal motility analysis system
Polyurethane Bands (Disk of 20 Bands) for HRaM catheters
DIVERSATEK HEALTHCARE, INC.
A86-4100
In Commercial Distribution

  • 00816734021538 ()
  • B019A8641000 ()
A86-4100

  • Manometric gastrointestinal motility analysis system
HRaM Kit includes 10 anorectal balloons, 20 polyurethane bands, and a suture removal kit
DIVERSATEK HEALTHCARE, INC.
A86-4110-10
In Commercial Distribution

  • 00816734021514 ()
  • B019A864110100 ()
A86-4110-10

  • Manometric gastrointestinal motility analysis system
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution

  • 00817100020490 ()


  • Diagnostic x-ray digital imaging system workstation
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution

  • 00817100020209 ()


  • Diagnostic x-ray digital imaging system workstation
EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution

  • 00817100020193 ()


  • Diagnostic x-ray digital imaging system workstation
Version >=3.0
STRYKER CORPORATION
521205090001
In Commercial Distribution

  • 07613327624328 ()
521205090001

  • Alarm application software
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