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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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HAMILTON-H900 - 07630002801546

No Description
Hamilton Medical AG
950004
In Commercial Distribution

  • 07630002801546 ()
950004

  • Heated respiratory humidifier

Breathing circuit set, coaxial - 07630002800945

Coaxial breathing circuit set with flow Sensor and Elbow Adapter for use with HAMILTON-C1/T1/MR1, 180 cm, adult/ pediatric, single-use
Hamilton Medical AG
260094
In Commercial Distribution

  • 07630002800945 ()


  • Ventilator breathing circuit, single-use

Breathing circuit set, coaxial - 07630002800921

Coaxial breathing circuit set with flow sensor and elbow adapter for use with HAMILTON-C1/T1/MR1, 180 cm, adult/ pediatric, single-use
Hamilton Medical AG
260087
In Commercial Distribution

  • 17630002800928 ()
  • 07630002800921 ()


  • Ventilator breathing circuit, single-use

Breathing circuit set, coaxial - 07630002800327

Coaxial breathing circuit set with expandable limb connection or use with all HAMILTON ventilators,180 cm, adult/ pediatric, single-use
Hamilton Medical AG
260206
In Commercial Distribution

  • 17630002800324 ()
  • 07630002800327 ()


  • Ventilator breathing circuit, single-use

Breathing circuit set, coaxial - 07630002800303

Coaxial breathing circuit set with flow sensor and expandable limb connection for use with all HAMILTON ventilators, 180 cm, adult/ pediatric, single-use
Hamilton Medical AG
260207
In Commercial Distribution

  • 17630002800300 ()
  • 07630002800303 ()


  • Ventilator breathing circuit, single-use

Multipac UniFlow anesthesia breathing system - 00816472022965

Multipac UniFlow anesthesia breathing system
Intersurgical Incorporated
2900078
In Commercial Distribution

  • 00816472022972 ()
  • 00816472022965 ()


  • Ventilator breathing circuit, single-use

Pneupac - 10610586038280

No Description
ICU MEDICAL, INC.
122004
In Commercial Distribution

  • 30610586038284 ()
  • 10610586038280 ()


  • Ventilator breathing circuit, single-use

FilmArray® Torch Module - 00815381029089

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

FilmArray® Torch System Base - 00815381029072

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

FilmArray® 2.0 Instrument - 00815381029058

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

BIOFIRE ® SPOTFIRE ® Module - 00815381020376

Used IVD Instrument (SPOTFIRE® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002-W
In Commercial Distribution

  • 00815381020376 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BIOFIRE ® SPOTFIRE ® Module - 00815381020369

IVD Instrument (SPOTFIRE ® Module).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0002
In Commercial Distribution

  • 00815381020369 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

BIOFIRE ® SPOTFIRE ® Control Station - 00815381020352

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

FilmArray® Torch Module - 00815381020284

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

FilmArray® Torch Module - 00815381020277

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

FilmArray® Torch System Base - 00815381020260

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

FilmArray® Torch System Base - 00815381020253

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

BIOFIRE ® SPOTFIRE ® Control Station - 00815381020055

IVD Instrument (SPOTFIRE ® Control Station).
BIOFIRE DIAGNOSTICS, LLC
FAST-ASY-0001
In Commercial Distribution

  • 00815381020055 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

FilmArray® 2.0 Instrument - 00815381020048

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

FilmArray® 2.0 Instrument - 00815381020031

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
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