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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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Blood Bank Computer System
2.0.0
In Commercial Distribution

  • 00860009119406 ()


  • Blood bank information system application software
The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.
NIDEK CO.,LTD.
AFC-330
In Commercial Distribution

  • 04987669100554 ()


  • Ophthalmic fundus camera
  • Eye anterior segment analyser software
  • Posterior eye segment analyser software
Computer-assisted dental injection syringe
Rønvig Dental Manufacturing A/S
2118
In Commercial Distribution

  • 05713513000942 ()


  • Dental computer assisted anaesthesia injection unit
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 25" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094346633 ()
QS-6AC-XXBXX

  • 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 with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8"), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094337518 ()
XSCRIBE-6AD-ACAAB

  • 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 with Trigger Module for TTL/analog signal output; Software kit; UK power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + XML
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094336801 ()
QS-6AC-CECAA

  • 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 with Trigger Module for TTL/analog signal output; Software kit; UK power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094336795 ()
QS-6AC-CGCAA

  • 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
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; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer, (includes 2 starter packs of full-grid paper - A4), Q-Stress premium transport cart with base, keyboard tray, storage shelf, large storage drawer, and side storage p
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094325256 ()
QS-6AD-CDCAB

  • Cardiopulmonary stress exercise monitoring system computer
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