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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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Bioserenity Cloud - 03615220004270

Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.
BIOSERENITY MEDICAL DEVICES GROUP
1012-21002-US
Not in Commercial Distribution

  • 03615220004270 ()


  • Bio-energy preliminary diagnosis system application software

BioPlex 2200 - 03610520563939

BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520563922

U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563922 ()

  • 1 Each
12001443

  • Laboratory instrument/analyser application software IVD

BioPlex® 2200 - 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520178904

U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5
BIO-RAD LABORATORIES, INC.
SW4.3_v5
In Commercial Distribution

  • 03610520178904 ()

  • 1 Each
12003844

  • Laboratory instrument/analyser application software IVD

NxStage Dosing Calculator - M535NX1272

No Description
NXSTAGE MEDICAL, INC.
NX1272
Not in Commercial Distribution

  • M535NX1272 ()


  • Clinical management support software

B-Right Screen Fetal Heart - 03760415600000

Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution

  • 03760415600000 ()


  • Ultrasound imaging system application software

AHI System - B823AHIV200

The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution

  • B823AHIV200 ()


  • Clinical management support software

Analytic for Hemodynamic Instability - B823AHIP100

Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Fifth Eye, Inc.
P1
In Commercial Distribution

  • B823AHIP100 ()


  • Clinical management support software

iQ®200 - 10837461002475

iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD
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