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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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Guardian Warmer w/ Control Box Hangers
Medela LLC
NGW2000
In Commercial Distribution

  • 10020451100996 ()
  • 00020451100999 ()


  • Conduction blood/fluid warmer
Guardian Warmer
Medela LLC
NGW1000
In Commercial Distribution

  • 10020451100989 ()
  • 00020451100982 ()


  • Conduction blood/fluid warmer
Refurbished IVD Instrument (FilmArray® Torch Module)
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0003-W
In Commercial Distribution

  • 00815381029089 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Torch System Base)
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0001-W
In Commercial Distribution

  • 00815381029072 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001-W
In Commercial Distribution

  • 00815381029058 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Used IVD Instrument (SPOTFIRE® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002-W
In Commercial Distribution

  • 00815381020376 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (SPOTFIRE ® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002
In Commercial Distribution

  • 00815381020369 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Used IVD Instrument (SPOTFIRE® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001-W
In Commercial Distribution

  • 00815381020352 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD instrument (Torch Module)
BIOFIRE DIAGNOSTICS, LLC
HTFA-SUB-0103
Not in Commercial Distribution

  • 00815381020284 ()
HTFA-SUB-0103R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Torch Module).
BIOFIRE DIAGNOSTICS, LLC
HTFA-SUB-0103
In Commercial Distribution

  • 00815381020277 ()
HTFA-SUB-0103

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Torch System Base).
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0104
Not in Commercial Distribution

  • 00815381020260 ()
HTFA-ASY-0104R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Torch System Base).
BIOFIRE DIAGNOSTICS, LLC
HTFA-ASY-0104
In Commercial Distribution

  • 00815381020253 ()
HTFA-ASY-0104

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (SPOTFIRE ® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001
In Commercial Distribution

  • 00815381020055 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001
Not in Commercial Distribution

  • 00815381020048 ()
FLM2-ASY-0001R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® 2.0 Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM2-ASY-0001
In Commercial Distribution

  • 00815381020031 ()
FLM2-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument (FilmArray® Instrument).
BIOFIRE DIAGNOSTICS, LLC
FLM1-ASY-0001
Not in Commercial Distribution

  • 00815381020024 ()
FLM1-ASY-0001R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument (FilmArray® Instrument)
BIOFIRE DIAGNOSTICS, LLC
FLM1-ASY-0001
Not in Commercial Distribution

  • 00815381020017 ()
FLM1-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Thermal Angel Ultra Operations Module
BOUND TREE MEDICAL, LLC
TA-UOM
In Commercial Distribution

  • 00815277022880 ()


  • Conduction blood/fluid warmer
Thermal Angel Ultra Emergency Pack, incl 2 IV Fluid Warmers, 2 Ext Sets, Battery, Charger, Cable
BOUND TREE MEDICAL, LLC
TA-UEP
In Commercial Distribution

  • 00815277022873 ()


  • Conduction blood/fluid warmer
Thermal Angel Standard Emergency Pack, incl 4 IV Fluid Warmers, 4 Ext Sets, Battery, Charger, Cable
BOUND TREE MEDICAL, LLC
TA-SEP
In Commercial Distribution

  • 00815277022866 ()


  • Conduction blood/fluid warmer
Thermal Angel Disposable Emergency Pack Reload Kit, incl 4 IV Fluid Warmers, 4 Ext Sets
BOUND TREE MEDICAL, LLC
TA-DEP
In Commercial Distribution

  • 00815277022859 ()


  • Conduction blood/fluid warmer
KIT, TA-200 BLOOD WARMER NON-STERILE DEMO
BOUND TREE MEDICAL, LLC
TA-200DEMOKIT
In Commercial Distribution

  • 00815277022842 ()


  • Conduction blood/fluid warmer
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCR-ADAA00000
In Commercial Distribution

  • B769ICRADAA00000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCP-ADAAA0000
In Commercial Distribution

  • B769ICPADAAA0000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
This contains the laptop, cube, power adapter and cables.
Genomadix Inc
2
In Commercial Distribution

  • G257ASM000960 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CPAP Tubing, 18 inch, single-pack
EXCELERON MEDICAL, INC.
CTUB-018-1
In Commercial Distribution

  • 10819989011184 ()
  • 00819989011187 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 4 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-040-1
In Commercial Distribution

  • 00819989011163 ()
  • 10819989011160 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 2 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-020-1
In Commercial Distribution

  • 00819989011149 ()
  • 10819989011146 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 6 ft (Spirit Labeled), single-pack
EXCELERON MEDICAL, INC.
CPAP-TUBE-6FT-SPL-1
In Commercial Distribution

  • 00819989011125 ()
  • 10819989011122 ()


  • Ventilator breathing circuit, single-use
CPAP Tubing, 10 ft, single-pack
EXCELERON MEDICAL, INC.
CTUB-100-1
In Commercial Distribution

  • 00819989011101 ()
  • 10819989011108 ()


  • Ventilator breathing circuit, single-use
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