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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 - 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

ICU Medical - 00840619099459

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

  • 00840619099459 ()
58400-000

  • Cardiac catheterization monitoring system

NA - 00840682104036

No Description
GE Healthcare Finland Oy
E-PiCCO-00
In Commercial Distribution

  • 00840682104036 ()


  • Patient monitoring system module, cardiac output

NA - 00840682103039

No Description
GE Healthcare Finland Oy
PiCCO Continuous Cardiac Output Cable
In Commercial Distribution

  • 00840682103039 ()


  • Patient monitoring system module, cardiac output

NA - 00840682103015

No Description
GE Healthcare Finland Oy
PiCCO Injectate Sensor Cable
In Commercial Distribution

  • 00840682103015 ()


  • Patient monitoring system module, cardiac output

ICU Medical - 00840619060268

TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip
ICU MEDICAL, INC.
52511
In Commercial Distribution

  • 10840619060265 ()
  • 00840619060268 ()
52511-14

  • Pulmonary artery balloon catheter, oximetric

ICU Medical - 00840619060244

TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip, Heparin Coated
ICU MEDICAL, INC.
52509
In Commercial Distribution

  • 10840619060241 ()
  • 00840619060244 ()
52509-14

  • Pulmonary artery balloon catheter, oximetric

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

LiDCO - 00843997017428

Kit, LiDCO Module, L
MASIMO CORPORATION
95098
In Commercial Distribution

  • 00843997017190 ()
  • 00843997017428 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 00843997017435

LiDCO Module, L, 1/Box
MASIMO CORPORATION
95099
In Commercial Distribution

  • 00843997017190 ()
  • 00843997017435 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 00843997002882

Kit, LiDCO Module
MASIMO CORPORATION
95060
In Commercial Distribution

  • 00843997017190 ()
  • 00843997002882 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 00843997001823

LiDCO Module
MASIMO CORPORATION
95059
In Commercial Distribution

  • 00843997017190 ()
  • 00843997001823 ()


  • General-purpose multi-parameter bedside monitor

RhythmAnalytics - 08885018690014

No Description
BIOFOURMIS SINGAPORE PTE. LTD.
1.1
In Commercial Distribution

  • 08885018690014 ()


  • Cardiopulmonary physiological parameter analysis software

Cardiologs Platform - B273CEA0

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

  • B273CEA0 ()


  • Cardiopulmonary physiological parameter analysis software

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 - 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

ICU Medical - 00887709094314

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

  • 00887709094314 ()
58400-000R

  • Cardiac catheterization monitoring system

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

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

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

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

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

CANON INC. - 04549292084696

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

  • 04549292084696 ()


  • Posterior eye segment analyser software

OBIX Perinatal Data System - 00868102000447

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.
Clinical Computer Systems, Inc.
9.0
In Commercial Distribution

  • 00868102000447 ()


  • Patient health record information system application software

OBIX Perinatal Data System - 00868102000423

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.
Clinical Computer Systems, Inc.
8.1
In Commercial Distribution

  • 00868102000423 ()


  • Patient health record information system application software

OBIX Perinatal Data System - 00868102000416

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.
Clinical Computer Systems, Inc.
10.0
In Commercial Distribution

  • 00868102000416 ()


  • Patient health record information system application software

HUMAC NORM (R) - 00860139000315

HUMAC NORM Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
504191
In Commercial Distribution

  • 00860139000315 ()
504191

  • Back/leg/chest dynamometer

HUMAC NORM - 00860139000308

HUMAC NORM Extremity System; Dynamometer
COMPUTER SPORTS MEDICINE INC.
502140
In Commercial Distribution

  • 00860139000308 ()
502140-00

  • Back/leg/chest dynamometer

BBCS Lab Interface Application V5.0 - 00860009119482

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119482 ()


  • Blood bank information system application software

Blood Bank Control System, V5.0 - 00860009119475

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119475 ()


  • Blood bank information system application software

BBCS Hospital Interface Application - 00860009119468

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119468 ()


  • Blood bank information system application software

BBCS BloodTrack Interface Application - 00860009119451

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119451 ()


  • Blood bank information system application software

ABO QuickPass V 1.0.0 - 00860009119444

ABO QuickPass is a software application intended to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations. ABO QuickPass works in tandem with compatible blood bank systems to identify repeat donors, retrieve the donor’s donation eligibility, and retrieve the donor history questionnaire appropriate for the donor and intended donation. Upon completion of ABO QuickPass all information which is entered by the donor is transferred to compatible blood bank systems. CASIs can be completed using the Internet via the ABO QuickPass web portal or at the donor site via the ABO QuickPass kiosk. CASIs which are completed via the web portal produce an encrypted barcode, which can be decrypted and imported on the day of donation into the ABO QuickPass kiosk for transfer of question responses to the facilities compatible blood bank system
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119444 ()


  • Blood bank information system application software

ABO Wheels V 1.0.0 - 00860009119437

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119437 ()


  • Blood bank information system application software

Blood Bank Control System 6.0 - 00860009119420

No Description
Blood Bank Computer System
6.0
In Commercial Distribution

  • 00860009119420 ()


  • Blood bank information system application software
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