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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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Norav 1200 Series PC-ECG - 07290110252649

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - L1 = Late Potential Analysis Module The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW L1
In Commercial Distribution

  • 07290110252649 ()
HASP-SW-K-L1-01

  • Cardiovascular risk evaluation interpretive software

Norav 1200 Series PC-ECG - 07290110252618

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW H1
In Commercial Distribution

  • 07290110252618 ()
HASP-SW-K-H1-01

  • Cardiovascular risk evaluation interpretive software

Welch Allyn, Inc. - 00732094319330

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; No patient cable; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094319330 ()
RSCRIBE-6EC-XXDXX

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094262896

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 16 monitoring slots (dual or 24 in. display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262896 ()
SCAC-AEB-CXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094320268

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; Z200+ thermal printer, (includes starter pack of full-grid paper - 8"), XScribe premium transport cart with base, keyboard tray, storage shelf, large storage drawer, and side storage pocket; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094320268 ()
XSCRIBE-6CC-XFAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308723

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; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and 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

  • 00732094308723 ()
QS-6CC-DFCXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355314

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

  • 00732094355314 ()
QS-6AC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094343786

Q-Stress 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, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094343786 ()
QS-6EC-DGEAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308501

Q-Stress 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, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094308501 ()
QS-6EC-XXEXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308457

Q-Stress 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, Q-Stress basic laser transport cart with keyboard tray; 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

  • 00732094308457 ()
QS-6XC-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer
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