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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mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC001.10.0001-EI
In Commercial Distribution

  • G474MC001100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MC001.06.0001-EI
In Commercial Distribution

  • G474MC001060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-THC
Mlife Diagnostics, LLC
MC001.05.0002EI
In Commercial Distribution

  • G474MC001050002EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
MC001.05.0001-EI
In Commercial Distribution

  • G474MC001050001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
M310601
In Commercial Distribution

  • G474M3106010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
M310501
In Commercial Distribution

  • G474M3105010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The T2Biothreat Panel component that contains the assay reagent
T2 BIOSYSTEMS, INC.
80-11394
In Commercial Distribution

  • M70880113930 ()
  • M70880113943 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Inspiration Ventilator System, model 7i with 12" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000102US0 ()
F7300000-7i-S-US

  • General-purpose intensive-care ventilator
Inspiration Ventilator System, model 7i with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000101US0 ()
F7300000-7i-L-US

  • General-purpose intensive-care ventilator
5 Panel Dip Drug Test, AMP500-COC150-MET500-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
30501-5
In Commercial Distribution

  • B29830501510 ()
30501-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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