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

  • 00732094259032 ()
XSCRIBE-6XC-XXXXB

  • Cardiopulmonary stress exercise monitoring system computer
CD, Labpro V4.42 Panel Update-07 LabPro V4.42 Panel Update-07 Kit (US, OUS) LabPro V4.42 System Kit wPanel Update-07 (US,OUS)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590703110 ()
  • 15099590703271 ()
  • 15099590703127 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
Surveyor Central Review Station - English language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262421 ()
SCREV-AAB-BXXXX

  • Centralized patient monitor
Surveyor Central Review Station - Italian language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262391 ()
SCREV-AEB-BXXXX

  • Centralized patient monitor
Surveyor Central Repeater Node - English language and CD manual; 220V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094285444 ()
SCREP-AAB-XXBXX

  • Centralized patient monitor
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
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
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
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