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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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FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5600050
In Commercial Distribution

  • D82856000500 ()


  • Orthodontic palate expander/teeth aligner, bonded
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
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
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
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; No lead set; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263183 ()
QS-6XC-BXXXX

  • Cardiopulmonary stress exercise monitoring system computer
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
XScribe/RScribe Server - version 6, current software CD; Software kit; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094257748 ()
XSERV-6AA-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer
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
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
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