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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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XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259476 ()
XSCRIBE-6CC-XXXXX

  • Cardiopulmonary stress exercise monitoring system computer
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
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
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
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
TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev L
Not in Commercial Distribution

  • 00850951007272 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation
TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev K
Not in Commercial Distribution

  • 00850951007104 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation
Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung
VORTRAN MEDICAL TECHNOLOGY 1, INC
PCK-5050
In Commercial Distribution

  • 20637320050503 ()
PCK-5050

  • Pulmonary resuscitator, pneumatic, single-use
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
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
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