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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. - 00817655020860

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 in. monitor with 1920 x 1080 resolution; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00817655020860 ()
HSCRIBE-6AA-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094259728

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; Isolation transformer 1000 VA Med Global; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259728 ()
XSCRIBE-6CC-CXBAC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259575

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi- clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259575 ()
XSCRIBE-6CC-DXBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259544

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 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

  • 00732094259544 ()
XSCRIBE-6CC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259391

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 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

  • 00732094259391 ()
XSCRIBE-6DC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259148

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; Software kit; 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

  • 00732094259148 ()
XSCRIBE-6GC-DXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259100

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; 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
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259100 ()
XSCRIBE-6GC-XXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094294545

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; 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 + CareFusion CP Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094294545 ()
XSCRIBE-6CC-DXBXE

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263466

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; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 25 in. leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263466 ()
QS-6CC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260694

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; Australia 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

  • 00732094260694 ()
XSCRIBE-6AC-BXAXX

  • Cardiopulmonary stress exercise monitoring system computer
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