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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Disposable Face Mask
Shenzhen 3Nod Electronics Co., Ltd.
14cm*9cm
In Commercial Distribution

  • 06922634100045 ()
  • 06922634100083 ()


  • Surgical/medical face mask, single-use
Disposable Face Mask
Shenzhen 3Nod Electronics Co., Ltd.
17.5cm*9.5cm
In Commercial Distribution

  • 06922634100038 ()
  • 06922634100090 ()


  • Surgical/medical face mask, single-use
Disposable Medical Face Mask
Shenzhen 3Nod Electronics Co., Ltd.
17.5cm*9.5cm
In Commercial Distribution

  • 06922634100007 ()
  • 06922634100106 ()


  • Surgical/medical face mask, single-use
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
CORETESTS, INC.
ACT21001-10
In Commercial Distribution

  • 10850042559656 ()
  • 00850042559659 ()
  • 00850042559512 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
CORETESTS, INC.
ACT21001-25
In Commercial Distribution

  • 00850042559635 ()
  • 10850042559632 ()
  • 00850042559512 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-4
In Commercial Distribution

  • 10850042559564 ()
  • 00850042559567 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-2
In Commercial Distribution

  • 10850042559557 ()
  • 00850042559550 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-5
In Commercial Distribution

  • 10850042559533 ()
  • 00850042559536 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-8
In Commercial Distribution

  • 10850042559151 ()
  • 00850042559154 ()
  • 00850042559109 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx COVID-19 Ag Test
CORETESTS, INC.
CO291-10
In Commercial Distribution

  • 10850042559144 ()
  • 00850042559147 ()
  • 00850042559116 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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