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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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Hokanson - 00817065021525

ARTERIAL AND VENOUS EXAM SOFTWARE - 220 V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021525 ()
03416

  • Peripheral vascular haemodynamic measurement application software

Hokanson - 00817065021518

ARTERIAL INFLOW SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms waveform calculations. Study results are used by the clinician to assess peripheral vascular function in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021518 ()
03415

  • Peripheral vascular haemodynamic measurement application software

Hokanson - 00817065021174

SOFTWARE INTERFACE BOX - An electrically-powered hardwired interface between one or multiple physiologic devices and a connected computer with dedicated physiologic software. The interface receives waveform and pressure data and formats the data before sending it to the computer. The interface also receives signals from the computer to activate a connected physiologic device. The device does not store data after it is sent to the computer.
D.E.HOKANSON, INC.
IB4
In Commercial Distribution

  • 00817065021174 ()
00725

  • Medical networking interface unit

Hokanson - 00817065021150

ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021150 ()
03413

  • Peripheral vascular haemodynamic measurement application software

Hokanson - 00817065021143

ARTERIAL AND VENOUS EXAM SOFTWARE - 110V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, a recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease in the patient. Includes interface box to connect computer to physiologic instruments and 110V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021143 ()
03412

  • Peripheral vascular haemodynamic measurement application software

VENDYS II - B546VENDYS1

No Description
ENDOTHELIX, INC.
JK-001V
In Commercial Distribution

  • B546VENDYS1 ()


  • Laser Doppler blood flowmeter

Cordiana Dx16 - 07649988821110

DICOM ECG Viewer/Editor
Cordiana Medical Informatics AG
0160100
In Commercial Distribution

  • 07649988821110 ()


  • Cardiology information system application software

SYNESCOPE - 08031527015040

No Description
MICROPORT CRM SRL
UPGRADE TO SYNESCOPE V3.10 USB
In Commercial Distribution

  • 08031527015040 ()


  • Electrocardiographic long-term ambulatory recording analyser

SYNESCOPE - 08031527015033

No Description
MICROPORT CRM SRL
NETWORK LICENCE V3,10 USB
In Commercial Distribution

  • 08031527015033 ()


  • Electrocardiographic long-term ambulatory recording analyser

EASYSCOPE - 08031527014944

No Description
MICROPORT CRM SRL
V3.10 UPG TO USB COM
In Commercial Distribution

  • 08031527014944 ()


  • Electrocardiographic long-term ambulatory recording analyser

EASYSCOPE - 08031527014913

No Description
MICROPORT CRM SRL
V3.10 Network Lic.USB
In Commercial Distribution

  • 08031527014913 ()


  • Electrocardiographic long-term ambulatory recording analyser

EASYSCOPE - 08031527014296

No Description
MICROPORT CRM SRL
V3.10 USB COM
In Commercial Distribution

  • 08031527014296 ()


  • Electrocardiographic long-term ambulatory recording analyser

SYNESCOPE - 08031527014289

No Description
MICROPORT CRM SRL
SYNESCOPE V3.10 USB
In Commercial Distribution

  • 08031527014289 ()


  • Electrocardiographic long-term ambulatory recording analyser

SYNECOM - 08031527013435

No Description
MICROPORT CRM SRL
V3.10
In Commercial Distribution

  • 08031527013435 ()


  • Electrocardiographic long-term ambulatory recording analyser

EndoPATx - 07290109225432

EndoPATx Device
ITAMAR MEDICAL LTD
EndoPATx
In Commercial Distribution

  • 07290109223377 ()
  • 07290109225432 ()
US1650007

  • Cardiovascular-risk peripheral arterial tonometry system

EndoPATx - 07290109225425

EndoPATx Device
ITAMAR MEDICAL LTD
EndoPATx
In Commercial Distribution

  • 07290109225425 ()
  • 07290109223353 ()
AS1650007

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225395

Endo PAT 2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225388 ()
  • 07290109225395 ()
US1650030

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225371

EndoPAT2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225364 ()
  • 07290109225371 ()
AS1650030

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225357

Endo PAT 2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225357 ()
  • 07290109225333 ()
  • 07290109225319 ()
US1650004

  • Cardiovascular-risk peripheral arterial tonometry system

Endo PAT 2000 - 07290109225340

EndoPAT2000 Device
ITAMAR MEDICAL LTD
Endo PAT 2000
In Commercial Distribution

  • 07290109225340 ()
  • 07290109225326 ()
  • 07290109225302 ()
AS1650004

  • Cardiovascular-risk peripheral arterial tonometry system

Accessories, EndoPATx - 07290109225227

Accessories for EndoPATx
ITAMAR MEDICAL LTD
Accessories, EndoPATx
In Commercial Distribution

  • 07290109225227 ()
AC0001650

  • Cardiovascular-risk peripheral arterial tonometry system

Anchors(30) for Endo PAT 2000 - 07290109225210

Anchors(30), EndoPAT
ITAMAR MEDICAL LTD
Anchors(30) for Endo PAT 2000
In Commercial Distribution

  • 07290109225210 ()
AC0572070

  • Cardiovascular-risk peripheral arterial tonometry system

Accessories for Endo PAT 2000 - 07290109225203

Accessories, EndoPAT2000
ITAMAR MEDICAL LTD
Accessories for Endo PAT 2000
In Commercial Distribution

  • 07290109225203 ()
AC0001600

  • Cardiovascular-risk peripheral arterial tonometry system

12 Pneumatic Endo probes for Endo PAT 2000 - 07290109225005

12 Pneumatic Endo probes
ITAMAR MEDICAL LTD
12 Pneumatic Endo probes for Endo PAT 2000
In Commercial Distribution

  • 07290109225005 ()
AC1600005

  • Cardiovascular-risk peripheral arterial tonometry system sensor

Affera™ Mapping System - 00763000871956

MAPPING SYSTEM AFR-00003 US
MEDTRONIC, INC.
AFR-00003
In Commercial Distribution

  • 00763000871956 ()


  • Cardiac mapping system

NA - 00763000871987

CART AFR-00013 SYSTEM US
MEDTRONIC, INC.
AFR-00013
In Commercial Distribution

  • 00763000871987 ()


  • Cardiac mapping system

NA - 00763000871833

PATCH AFR-00007 LOCATION REF 4PK US
MEDTRONIC, INC.
AFR-00007
In Commercial Distribution

  • 20763000871837 ()
  • 00763000871833 ()


  • Cardiac mapping system reference patch

EMS-XL - 07290102933082

Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
64 Ch. Console System
In Commercial Distribution

  • 07290102933082 ()
965-100-046

  • Cardiac electrophysiology analysis system

EMS-XL - 07290102933075

Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
64 Ch. Mobile System
In Commercial Distribution

  • 07290102933075 ()
965-100-036

  • Cardiac electrophysiology analysis system

EMS-XL - 07290102933068

Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
32 Ch. Console System
In Commercial Distribution

  • 07290102933068 ()
965-100-036

  • Cardiac electrophysiology analysis system

EMS-XL - 07290102933051

Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
32 Ch. Mobile System
In Commercial Distribution

  • 07290102933051 ()
965-100-035

  • Cardiac electrophysiology analysis system

EMS-XL - 07290102932832

Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
64 Ch. Lite System
In Commercial Distribution

  • 07290102932832 ()
965-100-145

  • Cardiac electrophysiology analysis system

EMS-XL - 07290102932818

Cardiac electrophysiology analysis system
MENNEN MEDICAL LTD.
32 Ch. Lite System
In Commercial Distribution

  • 07290102932818 ()
965-100-135

  • Cardiac electrophysiology analysis system

EnSite Precision™ - 15415067025934

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 15415067025934 ()
  • 05415067025937 ()
EN0020-P

  • Cardiac mapping system reference patch

CardioInsight™ - 00763000045456

SENSOR ARRAY VEST CITVST0004XL US
MEDTRONIC, INC.
CITVST0004XL
In Commercial Distribution

  • 00763000045456 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00763000045449

SENSOR ARRAY VEST CITVST0003L US
MEDTRONIC, INC.
CITVST0003L
In Commercial Distribution

  • 00763000045449 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00763000045432

SENSOR ARRAY VEST CITVST0002M US
MEDTRONIC, INC.
CITVST0002M
In Commercial Distribution

  • 00763000045432 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00763000045425

SENSOR ARRAY VEST CITVST0001S US
MEDTRONIC, INC.
CITVST0001S
In Commercial Distribution

  • 00763000045425 ()


  • Cardiac mapping system electrode array

N/A - 00763000118280

MAPPING SYSTEM CIT200 US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00763000118280 ()


  • Cardiac mapping system

Tablet Computer for OtoNova Pro - 05060396171512

Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution

  • 05060396171512 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

VistA Blood Establishment Computer Software - 00860271000952

No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.4.0
In Commercial Distribution

  • 00860271000952 ()


  • Blood bank information system application software

VistA Blood Establishment Computer Software - 00860271000945

No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.4
Not in Commercial Distribution

  • 00860271000945 ()


  • Blood bank information system application software

VistA Blood Establishment Computer Software - 00860271000938

No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.3
Not in Commercial Distribution

  • 00860271000938 ()


  • Blood bank information system application software

VistA Blood Establishment Computer Software - 00860271000921

No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.2
Not in Commercial Distribution

  • 00860271000921 ()


  • Blood bank information system application software

VistA Blood Establishment Computer Software - 00860271000914

No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.1
Not in Commercial Distribution

  • 00860271000914 ()


  • Blood bank information system application software

VistA Blood Establishment Computer Software - 00860271000907

No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.0
Not in Commercial Distribution

  • 00860271000907 ()


  • Blood bank information system application software

Connection Cable FO Computer/Digital-ECG - 04260166370164

No Description
Stockert GmbH
S7014
In Commercial Distribution

  • 04260166370164 ()


  • Electrical catheter connection cable, reusable

Mobile ENT Computer Cart, Assembly - 10815411020212

No Description
NEUROLOGICA CORP.
10-00159-001
In Commercial Distribution

  • 10815411020212 ()


  • CT system workstation

Sesamoid Plasty V2 Computer Kit - 00889024478978

No Description
Orthosoft Inc
20-8000-070-77
Not in Commercial Distribution

  • 00889024478978 ()
20-8000-070-77

  • Robotic surgical navigation system

STRAUMANN COMPUTER AIDED RESTORATION SERVICE - 07630031728623

Titanium single unit
Institut Straumann AG
Copings
In Commercial Distribution

  • 07630031728623 ()
010.2021

  • Custom-made dental crown, metal
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