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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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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
Dialysate Additive 10.4 grams Potassium Chloride to increase Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
PC10.4
In Commercial Distribution

  • B467PC104145 ()
  • B467PC104 ()

  • Weight: 10.4 Gram
PC12

  • Haemodialysis concentrate
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
LIFE®SoftPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 255 liters of oxygen. Provides 40 minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-2-101
In Commercial Distribution

  • B188LIFE21010 ()

  • Total Volume: 255 Liter


  • Oxygen refillable cylinder
LIFE®OxygenPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 566 liters of oxygen. Provides 90 minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-101
In Commercial Distribution

  • B188LIFE1010 ()

  • Total Volume: 566 Liter


  • Oxygen refillable cylinder
LIFE®OxygenPac is an easily portable, wall-mounted Emergency Oxygen Unit. A 0-25LPM, variable-flow regulator provides a 90 minute supply of oxygen at 6LPM.
Mv Life LLC
LIFE-025
In Commercial Distribution

  • B188LIFE0250 ()

  • Total Volume: 566 Liter


  • Fixed-regulator oxygen refillable cylinder
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
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