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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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Zvu® - 00816734022917

Zvu® HRiM Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIM-201-12-KIT
In Commercial Distribution

  • 00816734022917 ()

  • Catheter Gauge: 12 French
HRIM-201-12-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022894

Replacement Cable for Zvu® HRiM and HRaM Probes
DIVERSATEK HEALTHCARE, INC.
H12R-7610
In Commercial Distribution

  • 00816734022894 ()
H12R-7610

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022887

PriZm Base System
DIVERSATEK HEALTHCARE, INC.
PRIZMSYS
In Commercial Distribution

  • 00816734022887 ()
PRIZMSYS

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022610

PriZm® Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZMUPG-KIT
In Commercial Distribution

  • 00816734022610 ()
PRIZMUPG-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022467

Z/pH Probe
DIVERSATEK HEALTHCARE, INC.
CZAN-BT-62
In Commercial Distribution

  • 00816734022467 ()
  • B019CZANBT620 ()
CZAN-BT-62

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022412

Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-50
In Commercial Distribution

  • 00816734022412 ()
  • B019ZPNBS500 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-50

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022382

Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BG-07E
In Commercial Distribution

  • 00816734022382 ()
  • B019ZPNBG07E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BG-07E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022368

Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZPI-BS-46
In Commercial Distribution

  • 00816734022368 ()
  • B019ZPIBS460 ()

  • Catheter Gauge: 6.9 French
ZPI-BS-46

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022344

Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZIN-BS-51
In Commercial Distribution

  • 00816734022344 ()
  • B019ZINBS510 ()

  • Catheter Gauge: 6.4 French
ZIN-BS-51

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022337

Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZIN-BS-45E
In Commercial Distribution

  • 00816734022337 ()
  • B019ZINBS45E0 ()

  • Catheter Gauge: 6.4 French
ZIN-BS-45E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022313

Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BS-01E
In Commercial Distribution

  • 00816734022313 ()
  • B019ZANBS01E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BS-01E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022290

Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BG-44E
In Commercial Distribution

  • 00816734022290 ()
  • B019ZANBG44E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BG-44E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022023

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

Diversatek Healthcare - 00816734022009

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

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 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

H3+ - 00812345021684

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-AAA-XXXXX
In Commercial Distribution

  • 00812345021684 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021660

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-CAA-XXXXX
Not in Commercial Distribution

  • 00812345021660 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021653

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BAA-XXXXX
Not in Commercial Distribution

  • 00812345021653 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021646

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AAA-XXXXX
Not in Commercial Distribution

  • 00812345021646 ()


  • Electrocardiographic ambulatory recorder

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

Vision - 07613327624328

Version >=3.0
STRYKER CORPORATION
521205090001
In Commercial Distribution

  • 07613327624328 ()
521205090001

  • Alarm application software

SurgiCount - 07613327623079

+ PD Wall Mount
STRYKER CORPORATION
0894002003
In Commercial Distribution

  • 07613327623079 ()
0894-002-003

  • Electronic surgical sponge-counter

SurgiCount - 07613327622799

+ QBL Software
STRYKER CORPORATION
0894000005
In Commercial Distribution

  • 07613327622799 ()
0894-000-005

  • Electronic surgical sponge-counter

SurgiCount - 07613327622751

+ Sponge Counting Software
STRYKER CORPORATION
0894000003
In Commercial Distribution

  • 07613327622751 ()
0894-000-003

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327545364

APPLICATION
STRYKER CORPORATION
0794001090
In Commercial Distribution

  • 07613327545364 ()
0794001090

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327543094

+ APPLICATION
STRYKER CORPORATION
0694002090
In Commercial Distribution

  • 07613327543094 ()
0694-002-090

  • Electronic surgical sponge-counter

N/A - 07613327568998

QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327568981

+ EMR/QBL APPLICATION
STRYKER CORPORATION
0694-002-100
In Commercial Distribution

  • 07613327568981 ()
0694-002-100

  • Electronic surgical sponge-counter

H3R Holster - 00811331013931

H3R Holster (Rev A)
Tz Medical, Inc.
H3R-0027
In Commercial Distribution

  • 00811331013931 ()


  • Electrocardiographic ambulatory recorder

H3R USB Cable - 00811331013917

H3R USB Cable
Tz Medical, Inc.
H3R-0025
In Commercial Distribution

  • 00811331013917 ()


  • Electrocardiographic ambulatory recorder

Trident 3-Lead Cable - 00811331013887

Trident™ 40 3-Electrode Cable
Tz Medical, Inc.
H3R-0017
In Commercial Distribution

  • 00811331013887 ()


  • Electrocardiographic ambulatory recorder

SURGICOUNT - 07613327519518

+ CRADLE WALL MOUNT
STRYKER CORPORATION
0694002003
In Commercial Distribution

  • 07613327519518 ()
0694-002-003

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327515855

+ READER
STRYKER CORPORATION
0694002005
In Commercial Distribution

  • 07613327515855 ()
0694-002-005

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327513301

+ CRADLE POLE MOUNT
STRYKER CORPORATION
0694002004
In Commercial Distribution

  • 07613327513301 ()
0694-002-004

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327513295

+ CRADLE
STRYKER CORPORATION
0694002002
In Commercial Distribution

  • 07613327513295 ()
0694-002-002

  • Electronic surgical sponge-counter

N/A - 07613327509168

SURGICAL TABLET POWER SUPPLY
STRYKER CORPORATION
0794001080
In Commercial Distribution

  • 07613327509168 ()
0794-001-080

  • Electronic surgical sponge-counter
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