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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. - 00732094260601

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; UK 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

  • 00732094260601 ()
XSCRIBE-6AC-CXBAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260069

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; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260069 ()
XSCRIBE-6BC-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260021

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

  • 00732094260021 ()
XSCRIBE-6BC-XXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260014

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; Software kit; No power cord; No printer, no transport cart; IEC 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

  • 00732094260014 ()
XSCRIBE-6BC-XXBXC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260007

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; 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 + XML Orders + CareFusion CP Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260007 ()
XSCRIBE-6BC-XXBXD

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094324075

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; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), no transport cart; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094324075 ()
QS-6CC-XAAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094313819

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, no transport cart; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094313819 ()
QS-6CC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094301588

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; Australia power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301588 ()
HSCRIBE-6AA-BXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301571

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; Australia power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301571 ()
HSCRIBE-6AA-BXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301472

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; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094301472 ()
XSCRIBE-6AC-XXAXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094301465

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; 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

  • 00732094301465 ()
XSCRIBE-6AC-XXAXC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094294552

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, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders + CareFusion CP Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094294552 ()
XSCRIBE-6CC-DEBAD

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094294538

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; 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

  • 00732094294538 ()
XSCRIBE-6AC-DXBXE

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355154

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; Software kit; No 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

  • 00732094355154 ()
XSCRIBE-6BC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094346633

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 25" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094346633 ()
QS-6AC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308693

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; 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

  • 00732094308693 ()
XSCRIBE-6BC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094301076

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094301076 ()
QS-6AC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094286236

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; International\Canada power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286236 ()
HSCRIBE-6AA-DXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094259865

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Turnkey system with configured CPU, no display; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi- clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259865 ()
XSCRIBE-6CB-DEBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259834

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; US/Canada power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi- clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259834 ()
XSCRIBE-6CC-AXAAA

  • Cardiopulmonary stress exercise monitoring system computer
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