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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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library provides delivery of fluids in a controlled manner. It is a software controlled electromechanical device used for infusion of pharmaceutical drugs, blood, blood products and mixtures of patient therapy through administration sets.
BAXTER INTERNATIONAL INC.
35700BAX2
In Commercial Distribution

  • 00085412498683 ()
35700BAX2

  • Bedside infusion pump, single-channel
No Description
Medit Corp.
2.0
In Commercial Distribution

  • 08800026700869 ()


  • CAD/CAM software
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD
UIMS Viewing Station SC High Line
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000578 ()
K1029226

  • Basic diagnostic x-ray system operation software
UIMS Viewing Station SC Low Line
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000561 ()
K1029225

  • Basic diagnostic x-ray system operation software
UIMS Viewing Station
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000554 ()
K1028986

  • Basic diagnostic x-ray system operation software
Designated Medical Device, Critical Care Suite PACS 1.0
GE MEDICAL SYSTEMS, INC.
PACS 1.0
In Commercial Distribution

  • 00840682147231 ()


  • X-ray image interpretive software
No Description
VUNO Inc.
VN-M-30
In Commercial Distribution

  • 08800045800342 ()


  • X-ray image interpretive software
Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software with OUS Support
Covidien LP
WRSBTSW01
In Commercial Distribution

  • 10884521762633 ()


  • Multiparameter physiologic analysis workstation
Vital Sync Early Warning Score Application v1 Software with OUS Support
Covidien LP
EWSSW01
In Commercial Distribution

  • 10884521762626 ()


  • Multiparameter physiologic analysis workstation
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