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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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Salvin OraMEM® Resorbable Collagen Membrane - 15x20mm
SALVIN DENTAL SPECIALTIES, LLC
ORAMEM-15X20
In Commercial Distribution

  • 00841336100824 ()


  • Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.
PULMONX CORPORATION
LIA-01-001
In Commercial Distribution

  • 00811907031819 ()


  • CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134989 ()


  • CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134972 ()


  • CT system application software
Prometra Clinician Prgrammer
Flowonix Medical, Inc.
13828
In Commercial Distribution

  • 00810335020549 ()


  • Infusion pump programmer
Prometra Clinician Programmer Print Tool
Flowonix Medical, Inc.
12840
In Commercial Distribution

  • 00810335020266 ()


  • Infusion pump programmer
The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.
Flowonix Medical, Inc.
12861
In Commercial Distribution

  • 00810335020181 ()


  • Infusion pump programmer
The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Flowonix Medical, Inc.
12860
In Commercial Distribution

  • 00810335020174 ()


  • Infusion pump programmer
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).
Flowonix Medical, Inc.
12828
In Commercial Distribution

  • 00810335020167 ()


  • Infusion pump programmer
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.
Flowonix Medical, Inc.
11828
In Commercial Distribution

  • 00810335020129 ()


  • Infusion pump programmer
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