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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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Welch Allyn, Inc. - 00732094056112

Welch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Internal 802.11 a/b/g Wirel
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094056112 ()
85MTVEX-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094056075

Welch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and Coaxial Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Internal
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094056075 ()
85MTVXC-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094056006

Welch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, BP Cuff and Cord Management System, SureBP No n-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Internal 802.11 a/b/g Wireless Radio; 100-240 V, 50-60 Hz AC, IEC
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094056006 ()
85MTVXX-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094055849

Welch Allyn Connex Integrated Wall System with Masimo SpO2, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and PanOptic Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessor
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094055849 ()
85MXVEP-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094055597

Welch Allyn Connex Integrated Wall System with Nellcor SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and PanOptic Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support,
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094055597 ()
85NTVEP-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094055535

Welch Allyn Connex Integrated Wall System with Nellcor SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Internal 802.11 a/b/g Wire
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094055535 ()
85NTVEX-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094055467

Welch Allyn Connex Integrated Wall System with Nellcor SpO2, SureTemp Plus Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and Coaxial Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Interna
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094055467 ()
85NTVXC-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094055412

Welch Allyn Connex Integrated Wall System with Nellcor SpO2, SureTemp Plus Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and PanOptic Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Intern
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094055412 ()
85NTVXP-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094055207

Welch Allyn Connex Integrated Wall System with Nellcor SpO2, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and Coaxial Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessor
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094055207 ()
85NXVEC-B

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094036114

Temp; Skin Sensor, YSI #4499 Disposable, 100/box
WELCH ALLYN, INC.
901012
Not in Commercial Distribution

  • 00732094036114 ()
008-0228-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094036107

Temperature Probe, Reusable Skin/Surface
WELCH ALLYN, INC.
901010
In Commercial Distribution

  • 00732094036107 ()
008-0229-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094035995

Temperature Probe, General Purpose
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094035995 ()
008-0230-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094035575

ECG Cable, 3 Attached Snap Leads, AAMI, 12'
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035575 ()
008-0315-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094035230

Cuff Kit, one each of Large Adult, Small Adult and Thigh Cuff with twist-lock connector
WELCH ALLYN, INC.
901043
In Commercial Distribution

  • 00732094035230 ()
008-0324-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094034851

Temp; Skin Sensor, Adult, Reusable, Autoclavable, YSI #409AC
WELCH ALLYN, INC.
901010
In Commercial Distribution

  • 00732094034851 ()
008-0451-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094034172

Temp; Skin Sensor, Pediatric Reusable, Skin Surface, YS #427
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094034172 ()
008-0756-00

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094033687

Kit, Neonatal Cuffs, VSM3OO Series
WELCH ALLYN, INC.
901043
Not in Commercial Distribution

  • 00732094033687 ()
008-0851-01

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094033601

ECG Cable, 3 Attached Lead, Snap, AAMI, 1O'
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094033601 ()
008-0880-00

  • Multiple vital physiological parameter monitoring system, clinical

Care Assist - 00884838127449

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist Android
In Commercial Distribution

  • 00884838127449 ()
989803221541

  • Centralized patient monitor

Care Assist - 00884838127432

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor

Patient Information Center iX - 00884838127067

Patient Information Center iX
Philips Medizin Systeme Böblingen GmbH
4.4
In Commercial Distribution

  • 00884838127067 ()
866389

  • Centralized patient monitor

Care Assist - 00884838123724

Care Assist
Philips Medical Systems Hsg
Care Assist Android 4.2
In Commercial Distribution

  • 00884838123724 ()
989803221541

  • Centralized patient monitor

Care Assist - 00884838123717

Care Assist
Philips Medical Systems Hsg
Care Assist iOS 4.2
In Commercial Distribution

  • 00884838123717 ()
989803221531

  • Centralized patient monitor

Patient Information Center iX - 00884838122772

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
In Commercial Distribution

  • 00884838122772 ()
866389

  • Centralized patient monitor

MR-RT - 00884838122123

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software

Patient Information Center iX - 00884838121782

Patient Information Center iX
Philips Medical Systems Hsg
4.2
In Commercial Distribution

  • 00884838121782 ()
866389

  • Centralized patient monitor

MR-RT - 00884838112742

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
300005806303
In Commercial Distribution

  • 00884838112742 ()
781439

  • MRI system application software

Patient Information Center iX - 00884838112070

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
In Commercial Distribution

  • 00884838112070 ()
866389

  • Centralized patient monitor

MR-RT - 00884838107311

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Oy
RTgo 5.0 5
Not in Commercial Distribution

  • 00884838107311 ()
300005806302

  • MRI system application software

UroNav - 00884838107069

UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
UroNav 4
In Commercial Distribution

  • 00884838107069 ()
784039

  • Ultrasound imaging system application software

EchoNavigator - 00884838106437

Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Philips Medical Systems Nederland B.V.
EchoNavigator - 4
In Commercial Distribution

  • 00884838106437 ()


  • Angiographic x-ray system application software

Cydar EV - 05060508110002

The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set. Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution

  • 05060508110002 ()


  • Angiographic x-ray system application software

Tempus IC2 - 05060472442949

Tempus IC2 Patient Monitor
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-2001-R
Not in Commercial Distribution

867374

  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472442932

Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2, Temp & IBP
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1026-R
In Commercial Distribution

867423

  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472442925

Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2 & Temp
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1024-R
In Commercial Distribution

867422

  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472442918

Tempus Pro Rainbow - with Capnometry & with BT Dock
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1007-R
In Commercial Distribution

867421

  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472442901

Tempus Pro Rainbow - with Capnometry & without BT Dock
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1004-R
In Commercial Distribution

867420

  • Multiple vital physiological parameter monitoring system, clinical

ClinicalAccess Pro Connect - 00850033167221

The ClinicalAccess®, Pro Connect is a feature rich medical station designed to enhance efficiency and patient care in healthcare settings. The Pro Connect comes equipped with dual 22" monitors, ClearCam® PTZ with 12x optical zoom, Jabra conferencing microphone and speaker, integrated small form factor PC, and lockable device storage.
Globalmed Holdings, LLC
1.0
In Commercial Distribution

  • 00850033167221 ()
1CAP001-C01 / 1CAP001-C02

  • Medical image management system

First Exam Station - 00850033167139

Videoconferencing cart
Globalmed Holdings, LLC
First Exam Station
In Commercial Distribution

  • 00850033167139 ()


  • Medical image management system

LiteExam® Station (LES) - 00850033167092

Compact Desktop Telemedicine Station with Ergonomic User and Storage Features
Globalmed Holdings, LLC
1LES001
In Commercial Distribution

  • 00850033167092 ()
1LES001

  • Medical image management system
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