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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Face Mask, Padded, Toddler, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21133
In Commercial Distribution

  • 00816703025888 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Face Maks, Padded, Infant, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21132
In Commercial Distribution

  • 00816703025871 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Face Mask, Padded, Neonatal, Ambu
MEDSOURCE INTERNATIONAL LLC
MS-21131
In Commercial Distribution

  • 00816703025864 ()
Not Applicable

  • Aerosol face mask, rebreathing, single-use
Ear-Loop Mask
MEDSOURCE INTERNATIONAL LLC
MS-12125
In Commercial Distribution

  • 00816703024713 ()
  • 00816703024720 ()
Not Applicable

  • Public face mask, reusable
WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002-S
In Commercial Distribution

  • 10816862026860 ()
  • 00816862026863 ()
  • 00816862026856 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox with Holder; SD
WONDFO USA CO., LTD.
WV01P0001-2S
In Commercial Distribution

  • 10816862026150 ()
  • 00816862026153 ()
  • 00816862026146 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-25
In Commercial Distribution

  • 10816862024729 ()
  • 00816862024722 ()
  • 00816862024715 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 10 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-10
In Commercial Distribution

  • 10816862024705 ()
  • 00816862024708 ()
  • 00816862024692 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-5
In Commercial Distribution

  • 10816862024682 ()
  • 00816862024685 ()
  • 00816862024678 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0001-2
In Commercial Distribution

  • 10816862024668 ()
  • 00816862024661 ()
  • 00816862024654 ()


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