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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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C6 Sensor D - B146C6D0

No Description
BRAEMAR MANUFACTURING, LLC
02-01561
In Commercial Distribution

  • B146C6D0 ()


  • Electrocardiographic ambulatory recorder

C5 Monitor NOBT - B146C5M20

No Description
BRAEMAR MANUFACTURING, LLC
02-00116
In Commercial Distribution

  • B146C5M20 ()


  • Electrocardiographic ambulatory recorder

BTP-1000S Monitor - B146BTPM0

No Description
BRAEMAR MANUFACTURING, LLC
100-0045-02
In Commercial Distribution

  • B146BTPM0 ()


  • Electrocardiographic ambulatory recorder

BTP-1000L-2 BTI - B146BTPL210

No Description
BRAEMAR MANUFACTURING, LLC
02-01560
In Commercial Distribution

  • B146BTPL210 ()


  • Electrocardiographic ambulatory recorder

BTP-1000A - B146BTPA10

No Description
BRAEMAR MANUFACTURING, LLC
02-00143
In Commercial Distribution

  • B146BTPA10 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027112

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

  • 00812345027112 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027105

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

  • 00812345027105 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345027099

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

  • 00812345027099 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027044

Holter Recorder
MORTARA INSTRUMENT, INC.
BURH3PR
In Commercial Distribution

  • 00812345027044 ()


  • Electrocardiographic ambulatory recorder

Sonoma Orthopedic Products, Inc - 00816988010326

3.5mm Syndesmotic Drill, Non-sterile
ARTHREX, INC.
IN0066
Not in Commercial Distribution

  • 00816988010326 ()
IN0066

  • Patient monitoring system module, printing

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

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

M12 System - 00815187020754

SD Card (GI Label)
GLOBAL INSTRUMENTATION, LLC
000-400-0129
In Commercial Distribution

  • 00815187020754 ()
000-400-0129

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020600

M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0195
In Commercial Distribution

  • 00815187020600 ()
009-400-0195

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020594

M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5 3-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0194
In Commercial Distribution

  • 00815187020594 ()
009-400-0194

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020587

M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0193
In Commercial Distribution

  • 00815187020587 ()
009-400-0193

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020570

M5 Neck Lanyard
GLOBAL INSTRUMENTATION, LLC
009-400-0205
In Commercial Distribution

  • 00815187020570 ()
009-400-0205

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020563

M5 Recorder, USB Cable, USB Wall Charger, System Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0192
In Commercial Distribution

  • 00815187020563 ()
009-400-0192

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020556

M5 Recorder
GLOBAL INSTRUMENTATION, LLC
M5
In Commercial Distribution

  • 00815187020556 ()
009-400-0180

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020549

M5 USB Cable 1-Meter
GLOBAL INSTRUMENTATION, LLC
009-400-0178
In Commercial Distribution

  • 00815187020549 ()
009-400-0178

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020471

M5 4-Lead Patient Cable - RL Lead AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0171
In Commercial Distribution

  • 00815187020471 ()
009-400-0171

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020457

M5 3-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0169
In Commercial Distribution

  • 00815187020457 ()
009-400-0169

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020440

M5 2-Lead Patient Cable AHA
GLOBAL INSTRUMENTATION, LLC
009-400-0168
In Commercial Distribution

  • 00815187020440 ()
009-400-0168

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020433

M5 Patch Electrode, 2-Lead
GLOBAL INSTRUMENTATION, LLC
009-400-0167
In Commercial Distribution

  • 00815187020433 ()
009-400-0167

  • Electrocardiographic ambulatory recorder

Matrix Wearable - 00815187020112

M5 Patient Cable Cradle
GLOBAL INSTRUMENTATION, LLC
009-400-0206
In Commercial Distribution

  • 00815187020112 ()
009-400-0206

  • Electrocardiographic ambulatory recorder

H12+ - 00817655022086

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

  • 00817655022086 ()


  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00817655020853

H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00817655020853 ()
H3PLUS-CAE-XXXXX

  • Electrocardiographic ambulatory recorder

H12+ - 00817655020440

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

  • 00817655020440 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00817655020433

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

  • 00817655020433 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00817655020334

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

  • 00817655020334 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00817655022925

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

  • 00817655022925 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00817655022208

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

  • 00817655022208 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00817655022192

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

  • 00817655022192 ()


  • Electrocardiographic ambulatory recorder

Diversatek Healthcare - 00816734023488

Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023471

Anal Sphincter Electromyography Kit
DIVERSATEK HEALTHCARE, INC.
EMG-KIT
In Commercial Distribution

  • 00816734023471 ()
EMG-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023464

High Resolution Anorectal Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-KIT
In Commercial Distribution

  • 00816734023464 ()
HRAM-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023457

HRiM SD High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIMSD-KIT
In Commercial Distribution

  • 00816734023457 ()
HRIMSD-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023440

HRiM2 High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIM-KIT
In Commercial Distribution

  • 00816734023440 ()
HRIM-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023433

Manometry Starter Kit
DIVERSATEK HEALTHCARE, INC.
MANO-KIT
In Commercial Distribution

  • 00816734023433 ()
MANO-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734023426

Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734023167

MiVu Endo Cap Cable
DIVERSATEK HEALTHCARE, INC.
MI-CAB-02
In Commercial Distribution

  • 00816734023167 ()
MI-CAB-02

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734023143

MiVu Esophageal Endo Cap
DIVERSATEK HEALTHCARE, INC.
MI-ESO-CAP-3L
In Commercial Distribution

  • 00816734023143 ()
MI-ESO-CAP-3L

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734023112

inSIGHT Ultima Base System
DIVERSATEK HEALTHCARE, INC.
ULTSYS-II
In Commercial Distribution

  • 00816734023112 ()
ULTSYS-II

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734023105

inSIGHT Ultima Base Cart System
DIVERSATEK HEALTHCARE, INC.
ULTCART-II
In Commercial Distribution

  • 00816734023105 ()
ULTCART-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023099

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

  • 00816734023099 ()
PRIZMSYS-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023082

PriZm Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZM-KIT-II
In Commercial Distribution

  • 00816734023082 ()
PRIZM-KIT-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023075

PriZm Base Cart System
DIVERSATEK HEALTHCARE, INC.
PRIZMCART-II
In Commercial Distribution

  • 00816734023075 ()
PRIZMCART-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023068

PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H20-4500
In Commercial Distribution

  • 00816734023068 ()
H20-4500

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022924

Zvu® HRAM Starter Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-200-17-KIT
In Commercial Distribution

  • 00816734022924 ()

  • Catheter Gauge: 17 French
HRAM-200-17-KIT

  • Manometric gastrointestinal motility analysis system
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