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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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RESMED PTY LTD
4.2
In Commercial Distribution

  • 00619498000845 ()


  • Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • 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
Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
T2 BIOSYSTEMS, INC.
70-04933
In Commercial Distribution

  • M70870049330 ()


  • Magnetic particle separation instrument IVD
No Description
HANWOOLTPC Co., Ltd.
NC-15PLUS(48)
In Commercial Distribution

  • 08809886490019 ()


  • Magnetic particle separation instrument IVD
No Description
HANWOOLTPC Co., Ltd.
NC-15PLUS(32)
In Commercial Distribution

  • 08809886490002 ()


  • Magnetic particle separation instrument IVD
No Description
HANGZHOU ALLSHENG INSTRUMENTS CO.,LTD.
Auto-Pure 2400
In Commercial Distribution

  • 06975141982055 ()


  • Magnetic particle separation instrument IVD
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS-NPure32
In Commercial Distribution

  • 06974849369052 ()


  • Magnetic particle separation instrument IVD
End Tidal CO2 Monitoring Option For 980 Series Ventilator
Covidien LP
10084332
In Commercial Distribution

  • 30884521252954 ()


  • Ventilator application software
iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution

  • 06948538362075 ()


  • Ventilator application software
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