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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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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

NA - 00763000871987

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

  • 00763000871987 ()


  • Cardiac mapping system

Affera™ Mapping System - 00763000871956

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

  • 00763000871956 ()


  • 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

Connection Cable FO Computer/Digital-ECG - 04260166370164

No Description
Stockert GmbH
S7014
In Commercial Distribution

  • 04260166370164 ()


  • Electrical catheter connection cable, reusable

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 - 00860271000907

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

  • 00860271000907 ()


  • Blood bank information system application software

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

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

Mobile ENT Computer Cart, Assembly - 10815411020212

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

  • 10815411020212 ()


  • CT system workstation

STRAUMANN COMPUTER AIDED RESTORATION SERVICE - 07630031728623

Titanium single unit
Institut Straumann AG
Copings
In Commercial Distribution

  • 07630031728623 ()
010.2021

  • Custom-made dental crown, metal

EPOC HOST MOBILE COMPUTER, INT'L - 00809708046514

No Description
Epocal Inc
HH-0003-XU-00
Not in Commercial Distribution

  • 00809708046514 ()


  • Metabolic profile clinical chemistry analyser IVD

STRAUMANN COMPUTER AIDED RESTORATION SERVICE - 07630031717764

Custom Abutment Ti, RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717764 ()
040.689

  • Dental implant suprastructure, permanent, preformed

Isansys - 05060488680304

Data entry & local display point tablet computer, 10.5 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway SM-X200 – 10.5 - WiFi
In Commercial Distribution

  • 05060488680304 ()
Gateway SM-X200 – 10.5 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680267

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T515 - 10.1 - GSM
In Commercial Distribution

  • 05060488680267 ()
Gateway T515 - 10.1 - GSM

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680250

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T510 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680250 ()
Gateway T510 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680205

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - GSM
In Commercial Distribution

  • 05060488680205 ()
Patient Gateway T580 - 10.1 - GSM

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680182

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680182 ()
Gateway T580 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

N/A - 00851725007153

Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7450
In Commercial Distribution

  • 00851725007153 ()
RNS-6803-7450

  • Centralized patient monitor

N/A - 00851725007139

Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-3464
In Commercial Distribution

  • 00851725007139 ()
RNS-6803-3464

  • Centralized patient monitor

SeeMore - 00850921007035

USB ultrasound probe, general purpose/abdominal, with tablet computer
INTERSON CORP
ViewBladder 10
In Commercial Distribution

  • 00850921007035 ()
99-9008

  • Extracorporeal ultrasound imaging transducer, hand-held
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