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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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MGC Diagnostics - 00810016250043

Ultima System CPX
MEDICAL GRAPHICS CORPORATION
800810-021
In Commercial Distribution

800810-021

  • Cardiopulmonary stress exercise monitoring system

MGC Diagnostics - 00810016250036

Ultima System CPX - 120V UPS
MEDICAL GRAPHICS CORPORATION
800810-011
In Commercial Distribution

800810-011

  • Cardiopulmonary stress exercise monitoring system

MGC Diagnostics - 00810016250029

Ultima System CPX
MEDICAL GRAPHICS CORPORATION
800810-001
In Commercial Distribution

800810-001

  • Cardiopulmonary stress exercise monitoring system

MCG Diagnostics - 00810016250012

Express Series CCM
MEDICAL GRAPHICS CORPORATION
700023-906
In Commercial Distribution

700023-906

  • Cardiopulmonary stress exercise monitoring system

MGC Diagnostics - 00810016250005

Express Series CCM
MEDICAL GRAPHICS CORPORATION
700023-905
In Commercial Distribution

700023-905

  • Cardiopulmonary stress exercise monitoring system

COSMED - 18052400180249

This device is intended for use in clinical and research application to measure oxygen uptake.
C O S M E D SRL
Fitmate Med
In Commercial Distribution

  • 18052400180249 ()


  • Cardiopulmonary stress exercise monitoring system

COSMED - 18052400180201

The device is intended for use in clinical and research application to measure oxygen uptake. Fitmate is designed for the measurement of Resting Metabolic Rate only.
C O S M E D SRL
Fitmate
In Commercial Distribution

  • 18052400180201 ()


  • Indirect calorimeter

COSMED - 18052400180362

This device is intended for use in clinical and research application to measure oxygen uptake.
C O S M E D SRL
Fitmate GS
In Commercial Distribution

  • 18052400180362 ()


  • Indirect calorimeter

COSMED - 18052400180225

This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate Pro is designed for the measurement of Resting Metabolic Rate and maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.
C O S M E D SRL
Fitmate Pro
In Commercial Distribution

  • 18052400180225 ()


  • Cardiopulmonary stress exercise monitoring system

SAFEDRAW TA4812SDT BLUE - 00886333693610

No Description
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
689361
Not in Commercial Distribution

  • 50886333693615 ()
  • 00886333693610 ()
689361

  • Arterial blood sampling kit

VENOUS CLOSE LOOP SYSTEM - 00886333686957

Septum set connected with a 10cc syringe with touchguard stops at 10cc and a 60" Pressure tubing & a 3" small bore tube.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
688695
In Commercial Distribution

  • 50886333686952 ()
  • 00886333686957 ()

  • 10cc syringe stops at 10cc with a 60" pressure tube
688695

  • Invasive-pressure external transducer, single-use

TA-BPN - 00886333621590

single pack TA-BPN for blood sampling
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682159
In Commercial Distribution

  • 50886333621595 ()
  • 00886333621590 ()
682159

  • Arterial blood sampling kit

SAFEDRAW(TM) TA6012SDT - 00886333621453

A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682145
In Commercial Distribution

  • 50886333621458 ()
  • 00886333621453 ()

  • septum with 5cc syringe stops at 2cc
682145

  • Arterial blood sampling kit

SAFEDRAW(TM) TA4812SDT - 00886333621446

A Safedraw Septum connected to a 5cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682144
In Commercial Distribution

  • 50886333621441 ()
  • 00886333621446 ()

  • 5cc restricted syringe stops at 2cc
682144

  • Arterial blood sampling kit

SAFEDRAW(TM) TA4812SD - 00886333621361

A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 48” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682136
In Commercial Distribution

  • 50886333621366 ()
  • 00886333621361 ()

  • 3cc restricted syringe stops at 2cc
682136

  • Arterial blood sampling kit

SAFEDRAW(TM) TA6012SD - 00886333621354

A Safedraw Septum connected to a 3cc Restricted Syringe stops at 2cc via a 60” Pressure Tubing. It has a 12” Pressure tubing on the patient side and a colour set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682135
In Commercial Distribution

  • 50886333621359 ()
  • 00886333621354 ()

  • 3cc restricted syringe stops at 2cc
682135

  • Arterial blood sampling kit

FilmArray® 2.0 Instrument NGDS Configuration - 00851458005143

NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

MammoScreen - B885MAML2US0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software

MammoScreen - B885MAML0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software

BD FocalPoint™ GS Review Station - 00382904901899

BD FocalPoint™ GS Review Station Computer
BECTON, DICKINSON AND COMPANY
490189
In Commercial Distribution

  • 00382904901899 ()

  • Height: 33.2 Centimeter
  • Width: 55 Centimeter
  • Length: 59.2 Centimeter
490189

  • Cell morphology analyser IVD, manual

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116033

CompuFlo Epidural Computer Controlled Anesthesia System 110V
Milestone Scientific Inc.
EPI-6000-110
In Commercial Distribution

  • 00618874116033 ()


  • Electronic epidural space locator control unit

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116040

CompuFlo Epidural Computer Controlled Anesthesia System 220V
Milestone Scientific Inc.
EPI-6000-220
In Commercial Distribution

  • 00618874116040 ()


  • Electronic epidural space locator control unit

Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

Vita LE CR System - 60889971067708

NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner

Vita XE CR System - 60889971067685

NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner

QUANTIEN™ - 05415067023704

No Description
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067023704 ()
H702370

  • Cardiac catheterization laboratory computer

vMap Control Unit - 00860007954177

No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution

  • 00860007954177 ()


  • Cardiac mapping system computer

vMap Disposables - 00860007954108

No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer

Navik 3D - 00869781000308

Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed. Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care.
APN HEALTH
Navik 3D v2.0
In Commercial Distribution

  • 00869781000308 ()
200-00668

  • Cardiac mapping system computer

Sensis Vibe Combo - 04056869010205

Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007642
In Commercial Distribution

  • 04056869010205 ()


  • Cardiac catheterization laboratory computer

Sensis Vibe Hemo - 04056869010199

Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007641
In Commercial Distribution

  • 04056869010199 ()


  • Cardiac catheterization laboratory computer

Sensis Lite - 04056869010144

No Description
Siemens Healthcare GmbH
10764562
In Commercial Distribution

  • 04056869010144 ()


  • Cardiac catheterization laboratory computer

Sensis - 04056869010137

No Description
Siemens Healthcare GmbH
10764561
In Commercial Distribution

  • 04056869010137 ()


  • Cardiac catheterization laboratory computer

BR Surgical, LLC - 00840183528614

Keyboard for Image Capture System
BR Surgical, LLC
BR900-1306
In Commercial Distribution

  • 00840183528614 ()
BR900-1306

  • Computer/medical device keyboard

Volta AF-Xplorer - 03770019196038

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution

  • 03770019196038 ()
A002

  • Cardiac mapping system computer

VX1 - 03770019196007

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution

  • 03770019196007 ()
A001

  • Cardiac mapping system computer

Merge Hemo Link Assembly - 00842000100515

Merge Hemo 77-00327-00 Link Assembly
MERGE HEALTHCARE SOLUTIONS INC.
77-00327-00
In Commercial Distribution

  • 00842000100515 ()


  • Cardiac catheterization laboratory computer

Merge HEMO - 00842000100034

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.1
In Commercial Distribution

  • 00842000100034 ()


  • Cardiac catheterization laboratory computer

Merge Hemo - 00842000100010

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.0.4
In Commercial Distribution

  • 00842000100010 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Console with dPR - 10841716103763

RXi Console with dPR, US (p/n: 800939-010 )
ACIST MEDICAL SYSTEMS, INC.
019994
In Commercial Distribution

  • 10841716103763 ()
  • 30841716103767 ()


  • Cardiac catheterization laboratory computer
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