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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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Phasitron Kit, VDR, Turbo Hub, Single Patient
PERCUSSIONAIRE CORPORATION
A50096-D
Not in Commercial Distribution

  • 00849436000297 ()
  • 10849436000294 ()
A50096-D

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV with Phasitron Duo
PERCUSSIONAIRE CORPORATION
A50095-DUO
Not in Commercial Distribution

  • 00849436000280 ()
A50095-DUO

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV, Single Patient
PERCUSSIONAIRE CORPORATION
A50095-D
Not in Commercial Distribution

  • 10849436000270 ()
  • 00849436000273 ()
A50095-D

  • Ventilator breathing circuit, single-use
Phasitron Kit, Single Patient, IPV w/button
PERCUSSIONAIRE CORPORATION
A50095-1D
Not in Commercial Distribution

  • 00849436000266 ()
A50095-1D

  • Ventilator breathing circuit, single-use
Phasitron Kit, VDR, Single Patient
PERCUSSIONAIRE CORPORATION
A50094-D
In Commercial Distribution

  • 10849436000256 ()
  • 00849436000259 ()
A50094-D

  • Ventilator breathing circuit, single-use
CPAP tubing
Wellell Inc.
SF00001
In Commercial Distribution

  • 04716872506873 ()


  • Heated respiratory humidifier
XT Heated Humidifier (9S-006500)
Wellell Inc.
9S-006500
In Commercial Distribution

  • 04716872505647 ()


  • Heated respiratory humidifier
Breathing Circuit
ENTER MEDICAL CORPORATION
ENT-2023
In Commercial Distribution

  • 04719872109532 ()


  • Ventilator breathing circuit, single-use
Breathing Circuit
ENTER MEDICAL CORPORATION
ENT-2023
In Commercial Distribution

  • 04719872109501 ()


  • Ventilator breathing circuit, single-use
Adult Expandable Anesthesia Circuit Kit
FOREMOUNT ENTERPRISE CO., LTD.
450-1048
In Commercial Distribution

  • 04719871892244 ()


  • Ventilator breathing circuit, single-use
Anesthesia, Scavenger tubing, 22 mm
FOREMOUNT ENTERPRISE CO., LTD.
450-3021
In Commercial Distribution

  • 04719871892121 ()


  • Ventilator breathing circuit, single-use
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
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. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
GenePoc Inc
130840
In Commercial Distribution

  • 00628055344001 ()
130840

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XT Humidifier
Wellell Inc.
9S-006500
In Commercial Distribution

  • 14713025000094 ()
  • 04713025000097 ()


  • Heated respiratory humidifier
No Description
LIFEOS GENOMICS CORPORATION
md1000 Dx
In Commercial Distribution

  • 04719880531103 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Reusable humidifier chamber
VADI MEDICAL TECHNOLOGY CO., LTD.
G-314003
In Commercial Distribution

  • 14719894380930 ()
  • 04719894380933 ()
G-314003-CFS

  • Heated respiratory humidifier
Disposable ventilator circuit/ tubing (Without heated wire)
VADI MEDICAL TECHNOLOGY CO., LTD.
G-316002
In Commercial Distribution

  • 14719894380923 ()
  • 04719894380926 ()
G-316002-CFS

  • Ventilator breathing circuit, single-use
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680020 ()
QST-Dx1000-2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680013 ()
QST-Dx1000-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.
CHROMA ATE INC.
GenXplore q4800
In Commercial Distribution

  • 04719889100102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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