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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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Dialysate Additive 5.1 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
CC5.1
In Commercial Distribution

  • B467CC51220 ()
  • B467CC51 ()

  • Weight: 5.1 Gram
CC2

  • Haemodialysis concentrate
Dialysate Additive 15.7 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC15.7
In Commercial Distribution

  • B467CC157145 ()
  • B467CC157 ()

  • Weight: 15.7 Gram
CC10

  • Haemodialysis concentrate
PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B5507837810000 ()
783781000

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783781000 ()
78378100

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783780250 ()
78378025

  • Nucleic acid extraction/isolation kit IVD
Azur Nitrile Powder-Free, X-Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061705
In Commercial Distribution

  • D79010617053 ()
  • D79010617051 ()
  • D79010617050 ()
1061705

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061704
In Commercial Distribution

  • D79010617043 ()
  • D79010617041 ()
  • D79010617040 ()
1061704

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, Medium, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061703
In Commercial Distribution

  • D79010617033 ()
  • D79010617031 ()
  • D79010617030 ()
1061703

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061702
In Commercial Distribution

  • D79010617023 ()
  • D79010617021 ()
  • D79010617020 ()
1061702

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Azur Nitrile Powder-Free, X-Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061701
In Commercial Distribution

  • D79010617013 ()
  • D79010617011 ()
  • D79010617010 ()
1061701

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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