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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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AirWave Monitor - Portable/handheld monitor packaged with power transformer and electrical cord, data communication cable, reusable sensor cable, hang strap and software CD.
SONARMED, INC
AW-M0001
In Commercial Distribution

  • 00851334007001 ()


  • Endotracheal secretion monitoring system
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - German language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285413 ()
SCREP-BDB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - English language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262483 ()
SCREP-BAB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - Italian language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262476 ()
SCREP-BEB-XXXXX

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

  • 00732094313802 ()
QS-6FC-XXDXA

  • 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; 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

  • 00732094307085 ()
XSCRIBE-6DC-DEBXX

  • 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; 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 ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263282 ()
QS-6FB-DXEXX

  • 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; Software kit; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263268 ()
QS-6FC-DGDXX

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

  • 00732094343410 ()
QS-6CC-XXDXA

  • 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; Software kit; US/Canada power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8 in.), no transport cart; No lead set; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259858 ()
XSCRIBE-6CC-AAXXX

  • Cardiopulmonary stress exercise monitoring system computer
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