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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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Diversatek Healthcare - 00816734021972

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 - 00816734021965

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

  • 00816734021965 ()
  • B019H12R45000 ()
H12R-4500

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734021958

inSight Ultima® EMG Adaptor
DIVERSATEK HEALTHCARE, INC.
H12R-4300
In Commercial Distribution

  • 00816734021958 ()
  • B019H12R43000 ()
H12R-4300

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734021941

InSight Ultima® Central Unit
DIVERSATEK HEALTHCARE, INC.
H12R-2000
In Commercial Distribution

  • 00816734021941 ()
  • B019H12R20000 ()
H12R-2000

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021934

EFT Viscous Solution
DIVERSATEK HEALTHCARE, INC.
EFTV-12V
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021927

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

Diversatek Healthcare - 00816734021910

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

Diversatek Healthcare - 00816734021903

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

Diversatek Healthcare - 00816734021897

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

Diversatek Healthcare - 00816734021880

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

Diversatek Healthcare - 00816734021873

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

Diversatek Healthcare - 00816734021866

Motility Cart for inSIGHT Ultima® and PriZm Motility Systems
DIVERSATEK HEALTHCARE, INC.
CART5R
In Commercial Distribution

  • 00816734021866 ()
  • B019CART5R0 ()
CART5R

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021859

Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-5070
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734021842

MiVu Mucosal Integrity Cable
DIVERSATEK HEALTHCARE, INC.
MI-CAB-01
In Commercial Distribution

  • 00816734021842 ()
MI-CAB-01

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021835

Anorectal Balloon, 400CC TPE
DIVERSATEK HEALTHCARE, INC.
A86-4300-10
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021828

Air Charged Adapter Cable
DIVERSATEK HEALTHCARE, INC.
GIS-7010
In Commercial Distribution

  • 00816734021828 ()
GIS-7010

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021682

Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-1070
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021675

Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04-2000-S
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021668

Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04R-2500
In Commercial Distribution

  • 00816734021668 ()
  • B019A04R25000 ()
A04R-2500

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021545

HRaM Syringe/Stopcock Kit
DIVERSATEK HEALTHCARE, INC.
A86-4120
In Commercial Distribution

  • 00816734021545 ()
  • B019A8641200 ()
A86-4120

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021538

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

Diversatek Healthcare - 00816734021514

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

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020490

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

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020209

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

Konica Minolta SW (PACS) Exa - 00817100020193

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

Vasomedical™ EZ™ ECG Monitor - 00817980021389

EZ™ ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021389 ()
A13-0001-02-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth - 00817980020542

Model 2306 12 CH/ABP COMB Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 2306 Kit
In Commercial Distribution

  • 00817980020542 ()
A10-2306-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 2305 3 CH/ABP COMB Recorder w/Bluetooth - 00817980020535

Model 2305 3 CH/ABP COMB Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 2305 Kit
In Commercial Distribution

  • 00817980020535 ()
A10-2305-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 2304 12 CH/ABP COMB Recorder - 00817980020528

Model 2304 12 CH/ABP COMB Recorder
VASOMEDICAL, INC.
Model 2304 Kit
In Commercial Distribution

  • 00817980020528 ()
A10-2304-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 2303 3 CH/ABP COMB Recorder - 00817980020511

Model 2303 3 CH/ABP COMB Recorder
VASOMEDICAL, INC.
Model 2303 Kit
In Commercial Distribution

  • 00817980020511 ()
A10-2303-00

  • Electrocardiographic ambulatory recorder
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