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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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KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software
KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software
AVEA NIMV+VG SW KEY
Carefusion Corporation
63865
Not in Commercial Distribution

  • 10846446017564 ()


  • Ventilator application software
KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software
AVEA NIMV+VG SW KEY
VYAIRE MEDICAL, INC.
63865
In Commercial Distribution

  • 10190752175921 ()
63865

  • Ventilator application software
MagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes. Product Use Limitations: The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments.
CHROMA ATE INC.
MagXtract 3200
In Commercial Distribution

  • 04719889100010 ()


  • Magnetic particle separation instrument IVD
The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS8000
In Commercial Distribution

  • 00849811060991 ()
AS8000

  • Magnetic particle separation instrument IVD
The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS6000
In Commercial Distribution

  • 00849811051340 ()
AS6000

  • Magnetic particle separation instrument IVD
ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software
RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software
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