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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; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi- clips; No isolation transformer; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259216 ()
XSCRIBE-6FC-XXAXC

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU, no display; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi- clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259193 ()
XSCRIBE-6GB-AXAXA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU, no display; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259087 ()
XSCRIBE-6HB-AXAXA

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module; Software kit; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263503 ()
QS-6CC-AXAAA

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263398 ()
QS-6EB-DXEXB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263350 ()
QS-6EC-AXDXA

  • 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; 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
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; No power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12- lead lead set with 43" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094323726 ()
QS-6CC-XGAAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094321203 ()
QS-6EB-DGEXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface, Brazil INMETRO and ANVISA labeling
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094309676 ()
XSCRIBE-5BX-XXBRZ

  • Cardiopulmonary stress exercise monitoring system computer
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