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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; WAM Wireless Acquisition Module; 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

  • 00732094259506 ()
XSCRIBE-6CC-XXBXB

  • 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; Software kit; No 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

  • 00732094259124 ()
XSCRIBE-6GC-XXAXX

  • 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; Software kit; 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

  • 00732094259131 ()
XSCRIBE-6GC-DXBXX

  • 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; 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

  • 00732094332780 ()
XSCRIBE-6CC-DXBXB

  • 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; Software activation only; No power cord, activation only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094325607 ()
HSCRIBE-6AD-ZXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software
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
CARVER (1/pack) End: Double End, Size: CD 89-92, Handle: Standard; For more information: https://www.scottsdental.com/catalog/product/view/id/29892/s/carvers-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
128-1591
In Commercial Distribution

  • D77812815910 ()
128-1591

  • Dental restoration carver, multiple-material
CARVER (1/pack) End: Double End, Size: CD 3-6, Handle: Standard; For more information: https://www.scottsdental.com/catalog/product/view/id/29892/s/carvers-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
128-1587
In Commercial Distribution

  • D77812815870 ()
128-1587

  • Dental restoration carver, multiple-material
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
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