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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Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930804 ()
03038

  • Noninvasive haemodynamic monitoring system
Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930712 ()
03141

  • Noninvasive haemodynamic monitoring system
Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930705 ()
03038

  • Noninvasive haemodynamic monitoring system
Main Unit;
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930644 ()
00361

  • Noninvasive haemodynamic monitoring system
Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930637 ()
03141

  • Noninvasive haemodynamic monitoring system
No Description
GE Medical Systems (China) Co.,Ltd.
V2
In Commercial Distribution

  • 00840682102933 ()


  • General-purpose ultrasound imaging system
Accessory to Cube navigation systems. Device for registration.
Fiagon GmbH
v2
Not in Commercial Distribution

  • EFIAE0114301 ()
E 01 1430

  • ENT stereotactic surgery system
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: Linear distance measurements of anatomical structures, Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies, Measurement of brightness ratio between structures and in particular between the liver and the kidney, Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution

  • 03770023859011 ()


  • Ultrasound imaging system application software
  • Hepatic ultrasound elastography system
No Description
FIM MEDICAL
V2
In Commercial Distribution

  • 03760253450294 ()


  • Carbon monoxide breath analyser
Device is a charging and transportation case for up to 12 pair of FTM-DK insoles
FEETME
V2
In Commercial Distribution

  • 03760349820116 ()


  • Noninvasive device battery charger
No Description
NOTAL VISION LTD
V2
In Commercial Distribution

  • 07290017803005 ()
901F001

  • Macular pigment analyser
The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients.
BIOINTELLISENSE, INC.
BIOST05020F
In Commercial Distribution

  • 10850005949142 ()
  • 00850005949145 ()
SKU# B2-ST05-02-0-00-GY

  • Wearable multiple physiological parameter recorder, reusable
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: • Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. • Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. • If no gender is present, female referenced guideline values will be used for conclusions. • If Body Surface Area (BSA) is not present, indexed values cannot be provided. • During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
EKO.AI PTE. LTD.
2
In Commercial Distribution

  • 00860005876815 ()


  • Radiology DICOM image processing application software
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
REBRAIN
v2.0.1
In Commercial Distribution

  • 03770021895035 ()


  • Stereotactic system application software
Reusable Extension Cable
Oscor Inc.
ATAR-V2
Not in Commercial Distribution

  • 00885672102715 ()

  • Length: 250 Centimeter
ATAR-V2

  • Pacing/defibrillation lead electrical adaptor
ORT200 Covered Table Assembly V2
IMRIS Imaging, Inc.
113821-000
In Commercial Distribution

  • 00857534006738 ()


  • Basic diagnostic x-ray system table, powered
User's Manual, LiDCOrapid, V2, English
LIDCO LIMITED
HM 81-02 UM-044
In Commercial Distribution

  • 05060110521548 ()
HM 81-02 UM-044

  • General-purpose multi-parameter bedside monitor
Kit, Head Mounted Device, V2
POLARISAR, INC.
Revision 01
In Commercial Distribution

  • 00850046497148 ()
80-0007

  • Orthopaedic stereotactic surgery system
TROCAR VERSAPORT PLUS V2 LONG
STERILMED, INC.
AUT179097P
Not in Commercial Distribution

  • 10888551013208 ()
AUT179097P

  • Laparoscopic trocar blade, reprocessed
MAF v2 in Aqua Spectrum
CYTOCELL LIMITED
MPD22713
In Commercial Distribution

  • 05055844909250 ()


  • Assay development analyte-specific reagent IVD
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