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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. - 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. - 00732094318166

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; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094318166 ()
XSCRIBE-6XC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259711

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259711 ()
XSCRIBE-6CC-CXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259513

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; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259513 ()
XSCRIBE-6CC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259483

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; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259483 ()
XSCRIBE-6CC-XXBXX

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094259360

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259360 ()
XSCRIBE-6DC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259056

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; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259056 ()
XSCRIBE-6XC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259049

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 + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259049 ()
XSCRIBE-6XC-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer

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. - 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
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