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 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
STYLET RFS2-6-12 CLOSURE FAST V02
MEDTRONIC, INC.
RFS2-6-12
In Commercial Distribution

  • 00643169862999 ()

  • Working Length 12 CM
  • Outer Diameter: 2.0 Millimeter
  • Catheter Gauge: 6.0 French


  • Peripheral vascular electrocautery catheter, single-use
No Description
ATOM MEDICAL CORPORATION
61633
In Commercial Distribution

  • 04942962616331 ()

  • Depth: 110 Centimeter
  • Width: 84 Centimeter
61633

  • Open infant incubator
No Description
SOMNETICS INTERNATIONAL, INC.
Heated Humidifier
In Commercial Distribution

  • M9505030640 ()

  • Width: 6.625 Inch
  • Length: 12.25 Inch
  • Height: 5.1875 Inch
503064

  • Heated respiratory humidifier
The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation corrugated hose and equipped with a flow sensor adapter designed to stream the flow without turbulence and create a differential pressure in two points which are connected to differential pressure sensor used to calculate flow. The unique one-way check valve will only allow flow from ventilator to patient and prevent the exhaled flow flowing back to the ventilator. All exhaled flow will be forced out to the atmosphere through the exhausted port of the breathing valve. The 01CV8030 is specifically designed for use with o_two e700, e600 and e500 electronic transport ventilators.
O-Two Medical Technologies Inc
01CV8030
In Commercial Distribution

  • 17540195005331 ()
  • 07540195005334 ()

  • Weight: 260 Gram
  • Length: 6 Feet
01CV8030-CS

  • Ventilator breathing circuit, single-use
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
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382R
In Commercial Distribution

  • 30014613340089 ()
20382R

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382
In Commercial Distribution

  • 30014613339304 ()
20382

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR.
Meridian Bioscience Canada Inc
610210
In Commercial Distribution

  • 00628055344100 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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