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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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Transonic - 08774660000404

No Description
TRANSONIC SYSTEMS INC.
H9FX
Not in Commercial Distribution

  • 08774660000404 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 08774660000398

No Description
TRANSONIC SYSTEMS INC.
H7FX
Not in Commercial Distribution

  • 08774660000398 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 08774660000381

No Description
TRANSONIC SYSTEMS INC.
H6FX
Not in Commercial Distribution

  • 08774660000381 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 08774660000374

No Description
TRANSONIC SYSTEMS INC.
HCE101
Not in Commercial Distribution

  • 08774660000374 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 08774660000367

No Description
TRANSONIC SYSTEMS INC.
HCS3002-5
Not in Commercial Distribution

  • 08774660000367 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000350

No Description
TRANSONIC SYSTEMS INC.
HCS3021-5
Not in Commercial Distribution

  • 08774660000350 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000343

No Description
TRANSONIC SYSTEMS INC.
HCS3012-5
Not in Commercial Distribution

  • 08774660000343 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000336

No Description
TRANSONIC SYSTEMS INC.
HCS3011-5
Not in Commercial Distribution

  • 08774660000336 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000329

No Description
TRANSONIC SYSTEMS INC.
HCP01
Not in Commercial Distribution

  • 08774660000329 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000312

No Description
TRANSONIC SYSTEMS INC.
HC2TP
Not in Commercial Distribution

  • 08774660000312 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000305

No Description
TRANSONIC SYSTEMS INC.
HC2T
Not in Commercial Distribution

  • 08774660000305 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000299

No Description
TRANSONIC SYSTEMS INC.
HCM103
Not in Commercial Distribution

  • 08774660000299 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000282

No Description
TRANSONIC SYSTEMS INC.
HCM102
Not in Commercial Distribution

  • 08774660000282 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000275

No Description
TRANSONIC SYSTEMS INC.
HCM101
Not in Commercial Distribution

  • 08774660000275 ()


  • Thermal-dilution cardiac output unit

Cardiologs Platform - B273CEA0

Cardiologs ECG analysis platform
CARDIOLOGS TECHNOLOGIES
2.1.xx
In Commercial Distribution

  • B273CEA0 ()


  • Cardiopulmonary physiological parameter analysis software

Infinity PiCCO SmartPod Set - 04049098005074

No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS16734
In Commercial Distribution

  • 04049098005074 ()


  • Patient monitoring system module, cardiac output

Shp Unit PiCCO Pod - 04049098004619

No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS17441
In Commercial Distribution

  • 04049098004619 ()


  • Patient monitoring system module, cardiac output

HEMO/PICCO POD adapter, 10PIN - 04049098009485

No Description
DRAEGER MEDICAL SYSTEMS, INC.
3375958
In Commercial Distribution

  • 04049098009485 ()


  • Patient monitoring system module, cardiac output

PulsioFlex - 04250094501525

No Description
Pulsion Medical Systems SE
PC4000
In Commercial Distribution

  • 04250094501525 ()


  • Invasive arterial pressure cardiac output/oximetry monitor

PiCCO Module - 04250094501402

No Description
Pulsion Medical Systems SE
PC4510
In Commercial Distribution

  • 04250094501402 ()


  • Patient monitoring system module, cardiac output

ICU Medical - 00887709094314

Cogent Hemodynamic Monitoring System, Refurbished
ICU MEDICAL, INC.
58400-000R
In Commercial Distribution

  • 00887709094314 ()
58400-000R

  • Cardiac catheterization monitoring system

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

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

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

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

Remote Network Station - 00851725007290

Remote Network Station with Dell OptiPlex 7490 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7490
In Commercial Distribution

  • 00851725007290 ()
RNS-6803-7490

  • Centralized patient monitor

Remote Network Station - 00851725007238

Remote Network Station with Dell OptiPlex 7480 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7480
In Commercial Distribution

  • 00851725007238 ()
RNS-6803-7480

  • Centralized patient monitor

Remote Network Station - 00851725007191

Remote Network Station with Dell OptiPlex 7470 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7470
In Commercial Distribution

  • 00851725007191 ()
RNS-6803-7470

  • Centralized patient monitor

Remote Network Station - 00851725007184

Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7460
In Commercial Distribution

  • 00851725007184 ()
RNS-6803-7460

  • Centralized patient monitor

Gentuity - 00859910007049

Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse.
GENTUITY LLC
Gentuity Review Station
In Commercial Distribution

  • 00859910007049 ()
G80-01

  • Coronary optical coherence tomography system

BriefCase Triage - 07290018052297

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
23.y.z
In Commercial Distribution

  • 07290018052297 ()


  • Radiology DICOM image processing application software

BriefCase Triage - 07290018052273

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
22.y.z
In Commercial Distribution

  • 07290018052273 ()


  • Radiology DICOM image processing application software

BriefCase Triage - 07290018052259

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
21.x.y
In Commercial Distribution

  • 07290018052259 ()


  • Radiology DICOM image processing application software

BriefCase Triage - 07290018052211

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
19.x.y
In Commercial Distribution

  • 07290018052211 ()


  • Radiology DICOM image processing application software

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

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. - 00732094263824

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired 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 - A4), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export +
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263824 ()
QS-6AC-CFAAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263817

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired 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 - A4), Q-Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export +
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263817 ()
QS-6AC-CFCAA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263800

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired 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 - A4), Q-Stress basic transport cart with base 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 HL
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263800 ()
QS-6AC-CFEAA

  • Cardiopulmonary stress exercise monitoring system computer
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