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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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ICU Medical - 00887709048669

PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP.
ICU MEDICAL, INC.
46094-06
In Commercial Distribution

  • 10887709048666 ()
  • 00887709048669 ()
46094-06

  • In-line arterial blood sampling set

Unimed - 06945664859554

Repetitive blood oxygen probe /CSI/ finger clip/adult / 6.0m/new DB9M crank /CSM
Unimed Medical Supplies, Inc.
10470
In Commercial Distribution

  • 06945664859554 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664896061

Repetitive SpO2 Probe/Masimo/RD SET/New Lift Finger Clip/Adult/1.1M/653
Unimed Medical Supplies, Inc.
U403NC-254
In Commercial Distribution

  • 06945664896061 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664896030

Repetitive SpO2 probe/CSI/finger clip/children/3.0M/new DB9M crutches/Australian EMGP
Unimed Medical Supplies, Inc.
AC-PC-111-3
In Commercial Distribution

  • 06945664896030 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664893657

Repetitive SpO2 Probe/Nellcor/New Lifting Finger Clamp/Adult/With shading/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403LC-01
In Commercial Distribution

  • 06945664893657 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664893558

Repetitive SpO2 Probe/CSI/Finger Clip/Adult/3.0M/New DB9M Turn Head/CSM
Unimed Medical Supplies, Inc.
S410-750
In Commercial Distribution

  • 06945664893558 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664888622

Reusable SpO2 Sensor/GE Datex-Ohmeda/New lift finger clip/Adult//Scilicone Shield/3.0M
Unimed Medical Supplies, Inc.
U410LC-121
In Commercial Distribution

  • 06945664888622 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664888356

Reusable SpO2 Sensor/Masimo/New Type Finger Clip/Adult/1.1M/108G/1st CALL
Unimed Medical Supplies, Inc.
FCU403N-49R
In Commercial Distribution

  • 06945664888356 ()


  • Pulse oximeter probe, reusable

X-ray Imaging System (XIS) - 00866854000401

The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS. The software product integrates with the following components of the MPTS system: • X-ray generator & tube assembly • Amorphous silicon flat-panel detector • Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs. There are two defined methods of registration, 1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system. 2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution

  • 00866854000401 ()
n/a

  • CT system application software

ImageXL - 00861787000306

IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
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