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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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FLUID FILTER TRANSFER KIT
STRADIS MEDICAL LLC
TM.FFTK
In Commercial Distribution

  • M752TMFFTK5 ()
  • M752TMFFTK0 ()
  • M752TMFFTK1 ()


  • Fluid transfer set, general-purpose
IV START KIT
STRADIS MEDICAL LLC
IV-760
In Commercial Distribution

  • M752IV7600 ()
  • M765IV7605 ()
  • M752IV7605 ()


  • Peripheral intravenous catheterization support kit
Upper Extremity Drape
STRADIS MEDICAL, LLC
IN-9300CLF
Not in Commercial Distribution

  • M752IN9300CLF5 ()
  • M752IN9300CLF1 ()
  • M752IN9300CLF3 ()


  • Patient surgical drape, single-use
Dressing Change kit w/Sorbaview
STRADIS MEDICAL, LLC
IM1259
Not in Commercial Distribution

  • M752IM12595 ()
  • M752IM12590 ()
  • M752IM12596 ()


  • Wound dressing kit, medicated
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / MTD
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-39
In Commercial Distribution

  • M90107RD7065391 ()
  • M90107RD7065390 ()
  • M90107RD7065392 ()

  • Length: 75 Millimeter
07RD7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INTRODUCER,KIT 4FR X 11CM WITH .018X45CM SS/SS WIRE 21GX7CM NEEDLE
STRADIS MEDICAL, LLC
525-079
Not in Commercial Distribution

  • M7525250791 ()
  • M7525250793 ()
  • M7525250792 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 11 Centimeter
525-079

  • Vascular catheter introduction set, nonimplantable
5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038 R1
Not in Commercial Distribution

  • M752525038R10 ()
  • M752525038R13 ()
  • M752525038R15 ()


  • Vascular catheter introduction set, nonimplantable
Immunoassay for the detection of oxycodone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7101
In Commercial Distribution

  • M90107RD71011 ()
  • M90107RD71010 ()
  • M90107RD71012 ()

  • Length: 75 Millimeter
07RD7101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC/ OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-05
In Commercial Distribution

  • M90107RD7064051 ()
  • M90107RD7064050 ()
  • M90107RD7064052 ()

  • Length: 75 Millimeter
07RD7064-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Utopia HV Face Mask - Large
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694UTO2955 ()
  • M694UTO2953 ()
  • M694UTO2951 ()
UTO295

  • CPAP/BPAP face mask, reusable
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