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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 2.0 rebuilt - B146C6R20

No Description
BRAEMAR MANUFACTURING, LLC
02-01897
In Commercial Distribution

  • B146C6R20 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor A13, Verizon - B146C6M90

No Description
BRAEMAR MANUFACTURING, LLC
02-02118
In Commercial Distribution

  • B146C6M90 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor A13, T Mobile - B146C6M80

No Description
BRAEMAR MANUFACTURING, LLC
02-02119
In Commercial Distribution

  • B146C6M80 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor A10e, Verizon - B146C6M70

No Description
BRAEMAR MANUFACTURING, LLC
02-01804
In Commercial Distribution

  • B146C6M70 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor A10e, Sprint - B146C6M60

No Description
BRAEMAR MANUFACTURING, LLC
02-01800
In Commercial Distribution

  • B146C6M60 ()


  • Electrocardiographic ambulatory recorder

BTP-1000M - B146C6M50

No Description
BRAEMAR MANUFACTURING, LLC
02-01548
In Commercial Distribution

  • B146C6M50 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor - B146C6M40

No Description
BRAEMAR MANUFACTURING, LLC
02-01549
In Commercial Distribution

  • B146C6M40 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor UGW - B146C6M20

No Description
BRAEMAR MANUFACTURING, LLC
100-0048-02
In Commercial Distribution

  • B146C6M20 ()


  • Electrocardiographic ambulatory recorder

C6 Sensor 3.0 - B146C6E10

No Description
BRAEMAR MANUFACTURING, LLC
02-01846
In Commercial Distribution

  • B146C6E10 ()


  • Electrocardiographic ambulatory recorder

C6 Sensor - B146C6D10

No Description
BRAEMAR MANUFACTURING, LLC
02-01606
In Commercial Distribution

  • B146C6D10 ()


  • Electrocardiographic ambulatory recorder

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-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

C6 Sensor 2.5 rebuilt - B146C6R10

No Description
BRAEMAR MANUFACTURING, LLC
02-01889
In Commercial Distribution

  • B146C6R10 ()


  • Electrocardiographic ambulatory recorder

BTP-1000S Monitor - B146BTPM0

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

  • B146BTPM0 ()


  • Electrocardiographic ambulatory recorder

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

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Holter - B353UB12511

1AXe Wearable Biosensor
Lifesignals, Inc.
UB1251
In Commercial Distribution

  • B353UB12512 ()
  • B353UB12511 ()
  • B353UB12513 ()


  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
LP1251
In Commercial Distribution

  • B353LP12511 ()
LP1251_US

  • Electrocardiographic ambulatory recorder

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • 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

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 - 00816734023440

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

  • 00816734023440 ()
HRIM-KIT

  • 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

Ultima - 00816734023013

Ultima Cable for HRCA Manometry Probe (Lemo Connector)
DIVERSATEK HEALTHCARE, INC.
H12R-7210
In Commercial Distribution

  • 00816734023013 ()
H12R-7210

  • Manometric gastrointestinal motility analysis system

Ultima - 00816734023006

Ultima Cable for High Resolution Manometry Probe
DIVERSATEK HEALTHCARE, INC.
H12R-7110
In Commercial Distribution

  • 00816734023006 ()
H12R-7110

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734022931

MiVu Mucosal Integrity Starter Kit
DIVERSATEK HEALTHCARE, INC.
MIVU-KIT
In Commercial Distribution

  • 00816734022931 ()
MIVU-KIT

  • 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

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

MiVu - 00816734022900

MiVu Mucosal Integrity Inflation Syringe and Extension Tubing
DIVERSATEK HEALTHCARE, INC.
MI-SYR-01
In Commercial Distribution

  • 00816734022900 ()
  • 10816734022907 ()
MI-SYR-01

  • 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 - 00816734022870

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

  • 00816734022870 ()
PRIZMCART

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022863

Zvu® Anorectal Manometry Procedure Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-PROC-10
In Commercial Distribution

  • 00816734022863 ()
HRAM-PROC-10

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022856

Zvu® Anorectal Balloons
DIVERSATEK HEALTHCARE, INC.
HRAM-BAL-10
In Commercial Distribution

  • 00816734022856 ()
HRAM-BAL-10

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022825

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

  • 00816734022825 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022405

Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-46E
In Commercial Distribution

  • 00816734022405 ()
  • B019ZPNBS46E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-46E

  • 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
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