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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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TIMS System - 00850951007012

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 25J
Not in Commercial Distribution

  • 00850951007012 ()
061000-2000

  • Radiology picture archiving and communication system workstation

Welch Allyn, Inc. - 00732094285475

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; Custom display and control (Project Management required); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285475 ()
SCAC-AEB-EXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094308716

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; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 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

  • 00732094308716 ()
QS-6CC-DGCXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094307245

Q-Stress 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, 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

  • 00732094307245 ()
QS-6FB-DGEXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094300383

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; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094300383 ()
XSCRIBE-6DC-DXBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094299977

Q-Stress 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; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094299977 ()
QS-6FC-XXDAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094296297

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 + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094296297 ()
HSCRIBE-6AA-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094285994

Q-Stress 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; 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

  • 00732094285994 ()
QS-6FC-DXDAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260748

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; US/Canada 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

  • 00732094260748 ()
XSCRIBE-6AC-AXXXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260359

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; No lead set; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260359 ()
XSCRIBE-6AC-DXXXA

  • Cardiopulmonary stress exercise monitoring system computer
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