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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 - 07290110252533

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Single User License The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A1
In Commercial Distribution

  • 07290110252533 ()
HASP-SW-K-NEMS-A-01

  • Patient-administration information system application software

Welch Allyn, Inc. - 00732094088649

PCE-210 PC-Based Exercise Stress System; 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill interface cable, stress electrodes and manuals on CD)
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094088649 ()
CPSP-UN-UC-D

  • Diagnostic spirometer, professional

Welch Allyn, Inc. - 00732094314267

Surveyor Central Review Station - ; English language and CD manual; 220V power; Software kit; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export;
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094314267 ()
SCREV-AAB-BXBAX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094283464

X12+ 12-lead Telemetry Transmitter - 608 MHz, graphic display, alkaline battery, carry case, and hookup kit; German language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901150
Not in Commercial Distribution

  • 00732094283464 ()
X12PLUS-BDB-XXXXX

  • Patient monitoring system module, electrocardiographic

Welch Allyn, Inc. - 00732094071030

Welch Allyn Spirometer Upgrade for CP 200 Electrocardiograph, includes? Serial Port Adapter / Sensor ?Handle, Pressure Tubing with Connectors, Nose Clip, 4 pack of flow transducer tubes, 3 L calibration syringe, and CD
WELCH ALLYN, INC.
901049
In Commercial Distribution

  • 00732094071030 ()
100400

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094259926

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 and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; 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

  • 00732094259926 ()
XSCRIBE-6CA-DXAAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259827

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and 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

  • 00732094259827 ()
XSCRIBE-6CC-CDBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259803

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259803 ()
XSCRIBE-6CC-CDBAC

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259698

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; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and 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

  • 00732094259698 ()
XSCRIBE-6CC-DDBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259674

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; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259674 ()
XSCRIBE-6CC-DDBAC

  • Cardiopulmonary stress exercise monitoring system computer
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