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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AirFit P10 For Her Headgear Assembly
RESMED PTY LTD
62945
In Commercial Distribution

  • 00619498629459 ()
62945

  • CPAP/BPAP nasal mask, reusable
AIRFIT P10 FOR HER ADJUSTABLE HG
RESMED PTY LTD
62936
In Commercial Distribution

  • 00619498629367 ()
62936

  • CPAP/BPAP nasal mask, reusable
QUATTRO AIR FOR HER HEADGEAR STD
RESMED PTY LTD
62759
In Commercial Distribution

  • 00619498627592 ()
62759

  • CPAP/BPAP face mask, reusable
QUATTRO AIR FOR HER HEADGEAR SML
RESMED PTY LTD
62758
In Commercial Distribution

  • 00619498627585 ()
62758

  • CPAP/BPAP face mask, reusable
QUATTRO AIR FOR HER FFM MED
RESMED PTY LTD
62742
In Commercial Distribution

  • 00619498627424 ()
62742

  • CPAP/BPAP face mask, reusable
QUATTRO AIR FOR HER FFM SML
RESMED PTY LTD
62741
In Commercial Distribution

  • 00619498627417 ()
62741

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER HEADGEAR STD
RESMED PTY LTD
62507
In Commercial Distribution

  • 00619498625079 ()
62507

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER HEADGEAR SML
RESMED PTY LTD
62506
In Commercial Distribution

  • 00619498625062 ()
62506

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER FFM MED
RESMED PTY LTD
62502
In Commercial Distribution

  • 00619498625024 ()
62502

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER FFM SML
RESMED PTY LTD
62501
In Commercial Distribution

  • 00619498625017 ()
62501

  • CPAP/BPAP face mask, reusable
SWIFT FX FOR HER MASK SYS-SLM
RESMED PTY LTD
61541
In Commercial Distribution

  • 00619498615414 ()
61541

  • CPAP/BPAP nasal mask, reusable
SWIFT LT FOR HER HEADGEAR BUCKLE
RESMED PTY LTD
60740
In Commercial Distribution

  • 00619498607402 ()
  • 00619498607419 ()
60740

  • CPAP/BPAP nasal mask, reusable
SWIFT LT FOR HER HEADGEAR ASSY
RESMED PTY LTD
60595
In Commercial Distribution

  • 00619498605958 ()
60595

  • CPAP/BPAP nasal mask, reusable
SWIFT LT FOR HER MASK SYSTEM
RESMED PTY LTD
60588
In Commercial Distribution

  • 00619498605880 ()
60588

  • CPAP/BPAP nasal mask, reusable
Lifestyles His & Her Pleasure 12 ct
SURETEX LIMITED - BRANCH
9633
In Commercial Distribution

  • 30070907296333 ()
  • 10070907296339 ()
  • 00070907296332 ()
  • 80070907695599 ()


  • Basic male condom, Hevea-latex
Holter Monitor
MEMTEC CORPORATION
Model 950-3CH
In Commercial Distribution

  • 00860002827308 ()
1

  • Electrocardiographic long-term ambulatory recording analyser
The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Cardiospy ECG Holter recorders (EC-2H, EC-3H or EC-12H) as a system and the management, procession and evaluation of the recorded row data. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
USB-02 Dongle
In Commercial Distribution

  • 05999883490075 ()

  • Weight: 50 Gram
  • Width: 18.5 Millimeter
  • Width: 53 Millimeter
  • Length: 67.5 Millimeter
DEV-00USB-02

  • Electrocardiographic long-term ambulatory recording analyser
The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
EC-12H
In Commercial Distribution

  • 05999883490044 ()

  • Length: 67.5 Millimeter
  • Width: 53 Millimeter
  • Width: 18.5 Millimeter
  • Weight: 50 Gram


  • Electrocardiographic long-term ambulatory recording analyser
The battery powered Cardiospy ECG Holter System provides 1, 2, 3 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
EC-3H
In Commercial Distribution

  • 05999883490013 ()

  • Weight: 50 Gram
  • Width: 18.5 Millimeter
  • Width: 53 Millimeter
  • Length: 67.5 Millimeter


  • Electrocardiographic long-term ambulatory recording analyser
The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
EC-2H
In Commercial Distribution

  • 05999883490006 ()

  • Length: 67.5 Millimeter
  • Width: 53 Millimeter
  • Width: 18.5 Millimeter
  • Weight: 50 Gram


  • Electrocardiographic long-term ambulatory recording analyser
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