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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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Starling - 17290013030044

The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
CHEETAH MEDICAL (ISRAEL) LTD
CMS25
In Commercial Distribution

  • 07290013030047 ()
  • 17290013030044 ()
CMS25

  • Multiple vital physiological parameter monitoring system, clinical

BATH PROBE CABLE -SP5030 - 00886333640720

BATH PROBE CABLE with cable length 96". It has a 4-pin monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684072
In Commercial Distribution

  • 50886333640725 ()
  • 00886333640720 ()

  • cable length 96"
684072

  • Injectate temperature probe

Starling - 47290013030045

The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
CHEETAH MEDICAL (ISRAEL) LTD
CMS5
In Commercial Distribution

  • 07290013030047 ()
  • 47290013030045 ()
CMS5

  • Multiple vital physiological parameter monitoring system, clinical

Starling - 27290013030041

The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
CHEETAH MEDICAL (ISRAEL) LTD
CMS10
In Commercial Distribution

  • 07290013030047 ()
  • 27290013030041 ()
CMS10

  • Multiple vital physiological parameter monitoring system, clinical

CANON INC. - 04549292084696

No Description
CANON INC.
Ophthalmic Software Platform RX
In Commercial Distribution

  • 04549292084696 ()


  • Posterior eye segment analyser software

VISUPAC 500 - 04049471094077

The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented.
Carl Zeiss Meditec AG
VISUPAC 500
In Commercial Distribution

  • 04049471094077 ()

  • Height: 400 Millimeter
  • Footprint: 574 mm x 76mm
  • Weight: 14 Kilogram


  • Posterior eye segment analyser software

NON-MYDRIATIC AUTO FUNDUS CAMERA - 04987669100554

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

CompuDent STA - 00618874000011

STA Instrument
TRICOR SYSTEMS, INC.
STA-5110
In Commercial Distribution

  • 00618874000011 ()


  • Dental computer assisted anaesthesia injection unit

CALAJECT - 05713513000942

Computer-assisted dental injection syringe
Rønvig Dental Manufacturing A/S
2118
In Commercial Distribution

  • 05713513000942 ()


  • Dental computer assisted anaesthesia injection unit

Welch Allyn, Inc. - 00732094357073

QS6 WAM TTL TMX SYS Z200 PCRT AHA XML
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094357073 ()
QS-6KA-ACDAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094357066

QS6 WAM TTL TMX SYS Z200 PCRT AHA DICOM
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094357066 ()
QS-6KA-ACDAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355543

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; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 43" leadwires
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355543 ()
QS-6ED-AEAAA

  • 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. - 00732094355307

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; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer, (includes 2 starter packs of full- grid paper - 8"), Q-Stress premium transport cart with base, keyboard tray, storage shelf, la
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355307 ()
QS-6EA-ACEAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355291

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; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; Australia power cord; Z200+ thermal printer, (includes 2 starter packs of full- grid paper - 8"), Q-Stress premium transport cart with base, keyboard tray, storage shelf, la
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355291 ()
QS-6EA-BCDXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355277

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; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; Brazil power cord; Z200+ thermal printer, (includes 2 starter packs of full-grid paper - 8"), Q-Stress premium transport cart with base, keyboard tray, storage shelf, large
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355277 ()
QS-6EA-ECDXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355253

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; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; I
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355253 ()
QS-6ED-AFDAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355246

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; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; N
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355246 ()
QS-6ED-BEDXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355222

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; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; 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 + DI
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355222 ()
QS-6ED-DGEAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355208

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 ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; Brazil power cord; Z200+ thermal printer, (includes starter pack of full-grid paper - A4), XScribe premium transport cart with base, keyboard tray, storage shelf, large stor
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355208 ()
XSCRIBE-6AA-EGAXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355185

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

  • 00732094355185 ()
XSCRIBE-6AD-ACAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355178

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 in. monitor with 1920 x 1080 resolution; 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-cli
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355178 ()
XSCRIBE-6AD-CDBAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355154

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 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 medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355154 ()
XSCRIBE-6BC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094354577

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 and TM55 110V Treadmill; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer, (includes 2 starter packs of full-grid paper - 8"), Q-Stress premium transport cart with base, keyboard tray, storage shelf, large sto
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094354577 ()
QS6-MLTA1

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094353587

Q-Stress 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" monitor with 1920 x 1080 resolution; 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; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; R
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094353587 ()
QS-6FA-CEDXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094352672

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; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; No power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolatio
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094352672 ()
QS-6ED-XFDAB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094346633

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

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. - 00732094343410

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

Welch Allyn, Inc. - 00732094339444

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; Software kit; US/Canada power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8"), no transport cart; AHA 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

  • 00732094339444 ()
XSCRIBE-6AC-AAAAB

  • Cardiopulmonary stress exercise monitoring system computer
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