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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Flexible Patient Circuit, 3100A, MR850 in Non-Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
773997
In Commercial Distribution

  • 50190752155495 ()
773997

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A MR850 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
773996
In Commercial Distribution

  • 50190752155488 ()
773996

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A 380-88 in Non-Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771466
In Commercial Distribution

  • 50190752155471 ()
771466

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A 380-88/400-00 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771465
In Commercial Distribution

  • 50190752155464 ()
771465

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A 380-90 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771463
In Commercial Distribution

  • 50190752155457 ()
771463

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A, MR730 in Non-Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771375
In Commercial Distribution

  • 50190752155433 ()
771375

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A MR730 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771374
In Commercial Distribution

  • 50190752155426 ()
771374

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A 380-90 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
29028-005
Not in Commercial Distribution

  • 50190752155266 ()
29028-005

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit, 3100A MR850 in Non-Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
29028-004
Not in Commercial Distribution

  • 50190752155259 ()
29028-004

  • Ventilator breathing circuit, single-use
3100B Disposables Kit, Box of 4 / F&P 850
VYAIRE MEDICAL, INC.
11744-850K
In Commercial Distribution

  • 50190752155150 ()
11744-850K

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit w/Filter for 3100A (Box of 4)
VYAIRE MEDICAL, INC.
11518-850S
In Commercial Distribution

  • 50190752155143 ()
11518-850S

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit w/Filter for 3100A (Box of 4)
VYAIRE MEDICAL, INC.
11518-850L
In Commercial Distribution

  • 50190752155136 ()
11518-850L

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit w/Filter for 3100A (Box of 4)
VYAIRE MEDICAL, INC.
11518-730S
In Commercial Distribution

  • 50190752155129 ()
11518-730S

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit w/Filter for 3100A (Box of 4)
VYAIRE MEDICAL, INC.
11518-730L
In Commercial Distribution

  • 50190752155112 ()
11518-730L

  • Ventilator breathing circuit, single-use
Flexible Patient Circuit w/Filter for 3100A (Box of 4)
VYAIRE MEDICAL, INC.
11518-21VS
In Commercial Distribution

  • 50190752155105 ()
11518-21VS

  • Ventilator breathing circuit, single-use
No Description
GALEMED CORPORATION
3426
In Commercial Distribution

  • 44710810111240 ()
  • 94710810111245 ()
Disposable Humidification Chamber - Auto feeding (IV:120cm)

  • Heated respiratory humidifier
BUDDY LITE, BATTERY HOUSING AND HEATER UNIT, SWITZERLAND, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00019
Not in Commercial Distribution

  • 40896128002495 ()


  • Conduction blood/fluid warmer
ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, SWITZERLAND, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00025
Not in Commercial Distribution

  • 40896128002440 ()


  • Conduction blood/fluid warmer
BUDDY LITER, BATTERY HOUSING AND HEATER UNIT, NORTH AMERICAN, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00035
Not in Commercial Distribution

  • 30896128002542 ()


  • Conduction blood/fluid warmer
BUDDY LITE, BATTERY HOUSING AND HEATER UNIT, UK, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00018
Not in Commercial Distribution

  • 30896128002498 ()


  • Conduction blood/fluid warmer
ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, UK, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00024
Not in Commercial Distribution

  • 30896128002443 ()


  • Conduction blood/fluid warmer
No Description
NORTH EAST SCIENTIFIC INC
R-RFS2-6-12
In Commercial Distribution

  • B227RRFS26120 ()
R-RFS2-6-12

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc.
NORTH EAST SCIENTIFIC INC
R-RFS2-6-12
Not in Commercial Distribution

  • B227RRFS2612 ()
R-RFS2-6-12

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
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
Automated PCR analyzer
DXNA LLC
91004001
In Commercial Distribution

  • A91004001 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD PCR Cartridges 24EA
BECTON, DICKINSON AND COMPANY
437519
In Commercial Distribution

  • 30382904375196 ()
  • 00382904375195 ()
437519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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