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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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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
GOWN, ISOLATION LEVEL 1, BLUE, UNIVERSAL SIZE, HOOK & LOOP NECK, FULL BACK W/TIE AT WAIST, ELASTIC SLEEVE, 5EA/PK, 20PK/CS (100EA/CS)
Asp Global, LLC
HH-2020-060-1
In Commercial Distribution

  • 00840216123014 ()


  • Isolation gown, single-use
Elvarex Forte 3/Leg Extension from below knee to thigh/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77436-00022-00
In Commercial Distribution

  • 04019702258455 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Forte 3/Thigh High/Profile, Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77428-00804-00
In Commercial Distribution

  • 04019702546651 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
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
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
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