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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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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
LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM HEALTH, INC.
Logicon Caries Detector
In Commercial Distribution

  • 60889978008698 ()
8008690

  • General-purpose dental x-ray system application software
CS 3D IMAGING
CARESTREAM HEALTH, INC.
CS 3D Imaging Software
In Commercial Distribution

  • 60889975319582 ()
5319587

  • General-purpose dental x-ray system application software
DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software
CS IMAGING V7 WINDOWS EDITION
CARESTREAM HEALTH, INC.
CS Imaging Suite
In Commercial Distribution

  • 60889975314303 ()
5314307

  • General-purpose dental x-ray system application software
CS IMAGING V7 update only
CARESTREAM HEALTH, INC.
CS Imaging Software V7
Not in Commercial Distribution

  • 60889971745927 ()
1745926

  • General-purpose dental x-ray system application software
Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software
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