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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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Welch Allyn, Inc. - 00732094350753

HS6 SERVER RX KIT DICOM PDF XML
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094350753 ()
HSERV-6BA-XXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094345643

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094345643 ()
HSCRIBE-6AC-DXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094338812

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094338812 ()
HSCRIBE-6AC-CXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094327496

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US power cord; HP LaserJet 110V printer; Rx Report Export (UNIPRO and waveform XML) + XML Orders
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094327496 ()
HSCRIBE-6AA-AAXXD

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094325607

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094325607 ()
HSCRIBE-6AD-ZXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094325591

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094325591 ()
HSCRIBE-6AC-BXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094323917

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; No power cord-US option only; No printer; Rx Report Export (UNIPRO and waveform XML) + XML Orders
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094323917 ()
HSCRIBE-6AC-YXXXD

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094323191

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094323191 ()
HSCRIBE-6AD-ZXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094309478

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU, no display; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094309478 ()
HSCRIBE-6AB-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301588

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301588 ()
HSCRIBE-6AA-BXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301571

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301571 ()
HSCRIBE-6AA-BXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301564

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301564 ()
HSCRIBWS-6AA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301557

HScribe Download Workstation - version 6 for Holter recording import. Includes current software CD, H3+ USB download cable, and H12+ CF card reader; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301557 ()
HSCRIBWS-6BA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094300482

KIT SW HS RV DWN PDF XML EXPOR
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094300482 ()
HS6-HRDP

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094296297

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094296297 ()
HSCRIBE-6AA-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094286236

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; International\Canada power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286236 ()
HSCRIBE-6AA-DXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094286151

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286151 ()
HSCRIBE-6AD-ZXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094286137

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286137 ()
HSCRIBE-6AD-ZXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272468

SOFTWARE H-SCRIBE VER 4.34
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094272468 ()
11013-018-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264128

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; International\Canada power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094264128 ()
HSCRIBE-6AA-DXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264111

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU, no display; International\Canada power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094264111 ()
HSCRIBE-6AB-DXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264104

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; US power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264104 ()
HSCRIBE-6AC-AXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264098

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264098 ()
HSCRIBE-6AC-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264081

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264081 ()
HSCRIBE-6AC-BXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264074

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264074 ()
HSCRIBE-6AC-CXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264067

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264067 ()
HSCRIBE-6AC-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264050

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264050 ()
HSCRIBE-6AC-DXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264043

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264043 ()
HSCRIBE-6AC-DXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264036

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264036 ()
HSCRIBE-6AC-DXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264029

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264029 ()
HSCRIBE-6AC-DXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264012

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; No power cord-OUS option only; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264012 ()
HSCRIBE-6AC-XXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094264005

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; No power cord-OUS option only; No printer; Rx Report Export (UNIPRO and waveform XML) + XML Orders
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264005 ()
HSCRIBE-6AC-XXXXD

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263992

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; No power cord-OUS option only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263992 ()
HSCRIBE-6AC-XXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263985

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263985 ()
HSCRIBWS-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263978

HScribe Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263978 ()
HSERV-6AA-XXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094261301

Burdick Vision V3.x upgrade to Vision Express
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094261301 ()
UPGVHE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094257779

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094257779 ()
HSCRIBE-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Novi Software - 00856298006237

Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution

  • 00856298006237 ()
101633

  • Electrocardiographic long-term ambulatory recording analyser application software

TeleSense Software - 00856298006213

Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution

  • 00856298006213 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

GN Hearing - 05708296137428

SPEEDLINK UNIT
Gn Hearing A/S
15874200
In Commercial Distribution

  • 05708296137428 ()


  • Hearing aid/implant system programming interface unit

GN Hearing - 05708296051496

SPEEDLINK,COMPL PCK
Gn Hearing A/S
15861300
In Commercial Distribution

  • 05708296051496 ()


  • Hearing aid/implant system programming interface unit

Interacoustics - 05711117199765

No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software

Interacoustics - 05711117180497

No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution

  • 05711117180497 ()


  • Camera application software

Vital-Trac - 00850070776028

PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software

Synergy ODM - 00852683007049

Synergy ODM 4.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.09
In Commercial Distribution

  • 00852683007049 ()


  • Camera application software

Synergy ODM - 00852683007032

Synergy ODM 4.08 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.08
In Commercial Distribution

  • 00852683007032 ()


  • Camera application software

Synergy ODM - 00852683007025

Synergy ODM 4.07 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.07
In Commercial Distribution

  • 00852683007025 ()


  • Camera application software

Synergy ODM - 00852683007018

Synergy ODM 4.06 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.06
In Commercial Distribution

  • 00852683007018 ()


  • Camera application software

Synergy ODM - 00852683007001

Synergy ODM 4.05 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
4.05
In Commercial Distribution

  • 00852683007001 ()


  • Camera application software

Rhythm Express - 00860000272414

The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network. The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.
VIVAQUANT, INC.
RX-1
In Commercial Distribution

  • 00860000272414 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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