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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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Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; WAM Wireless Acquisition Module; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi- clips for WAM ONL
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094358292 ()
QS-6FA-AEDAA

  • Cardiopulmonary stress exercise monitoring system
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; WAM Wireless Acquisition Module; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips for WAM ONLY; Isolation transformer 1000 VA Med Global; Report Export + XML O
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094358285 ()
QS-6FA-AGDAA

  • Cardiopulmonary stress exercise monitoring system
Q-Stress Cardiac ver 6 w/ adult & ped interp; inc current sfw & user manual CD; AM12Q Wired Acquisition Module w/ Trigger Module for TTL/analog signal output;Turnkey system w/ config CPU and color LCD 24" mon w/ 1920 x 1080 resUK pwr cord; Z200+ thermal printer,(2 packs of full-grid paper A4), Q-Stress premium cart w/ base, keyboard tray,shelf, large drawer,side storage pocket; IEC 10 wire, 12-lead set with medi-clips; Iso trans 1000 VA Med Global;Export XML Orders
WELCH ALLYN, INC.
901007
In Commercial Distribution

  • 00732094318425 ()
QS-6GD-CFEAA

  • Cardiopulmonary stress exercise monitoring system computer
SC Station S4 Wifi telemetry and S12/S19 multiparameter bedside monitor capabilities EN CD man Config CPU custom SCNODE config must be determined w/ 110V pwr and dual color LCD 24" high res monitor 16 hard wired pat. monitor slots and 0 telemetry ch dual display recommend Local storage 600 days no network printer VERITAS analysis algorithm 12-lead ECG interp ext. arrhythmia 12-lead ST segment monitor and hemodynamic calc required for options with hard wired pat. monitor slots No full disclosure
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094318234 ()
SCSYS-IAA-DBFXX

  • Centralized patient monitor
The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CALPHU-CH50
In Commercial Distribution

  • B24280CALPHUCH500 ()
80-CALPHU-CH50

  • Calprotectin IVD, kit, chemiluminescent immunoassay
The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CALPHU-CH01
In Commercial Distribution

  • B24280CALPHUCH010 ()
80-CALPHU-CH01

  • Calprotectin IVD, kit, chemiluminescent immunoassay
Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00850057636000 ()


  • Radiology DICOM image processing application software
The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument. The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit).
NETECH CORPORATION
DELTA 3300
In Commercial Distribution

  • B3356600 ()
660

  • External defibrillator tester
Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Clinical Foot Software CD with Hoof-E Map, pre-configured wireless router, 4 Hoof 3200E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, (2) 10 ft. Cuff Cables, Waist Belt, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, (4) 6188 Urethane Sensor Protective Sheets, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only)
Tekscan, Inc.
Hoof VersaTek Wireless System
In Commercial Distribution

  • B970HVW20 ()
HVW2

  • Body-surface pressure mapping system
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