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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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Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 24 monitoring slots (dual or 24" display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094347197 ()
SCAC-AAA-DXCXX

  • Centralized patient monitor
TIMS 2000 FEES connects to USB Endo scopes. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS-FEES-USB 2A
Not in Commercial Distribution

  • 00850951007869 ()
061000-FEES-USB

  • Radiology picture archiving and communication system workstation
Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Software Package on CD Special edition for GE Health Care.
Norav Medical GmbH
ECGUSB1DEX Kit
In Commercial Distribution

  • 04260498567003 ()
ECGUSB1DEX-K-00-EC3-12

  • Electrocardiographic signal amplifier
Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Software Package on CD Special edition for GE Health Care.
Norav Medical GmbH
ECGUSB1DEX Kit
In Commercial Distribution

  • 04260498566884 ()
ECGUSB1DEX-K-00-EC3-11

  • Electrocardiographic signal amplifier
Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Software Package on CD Special edition for GE Health Care.
Norav Medical GmbH
ECGUSB1DEX Kit
In Commercial Distribution

  • 04260498566099 ()
ECGUSB1DEX-K-00-EC3-08

  • Electrocardiographic signal amplifier
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL License for 50 Users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-Q 50
In Commercial Distribution

  • 07290110252588 ()
HASP-SW-K-NEMS-Q-50-03

  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL License for 250 Users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-Q 250
In Commercial Distribution

  • 07290110252571 ()
HASP-SW-K-NEMS-Q-250-4

  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL License for 10 Users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-Q 10
In Commercial Distribution

  • 07290110252564 ()
HASP-SW-K-NEMS-Q-10-02

  • Patient-administration information system application software
Surveyor Central Additional Control - configured CPU German language and CD manual; 220V power; Custom display and control (Project Management required); No printer; Dual color LCD 24 in. monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285505 ()
SCAC-ADB-EXDXX

  • Centralized patient monitor
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; International power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with medi-clip ends; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263114 ()
RSCRIBE-6BC-DXDDX

  • Electrocardiograph, professional, multichannel
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