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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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24G x 6mm x 12" Clear-View MAX "Sub-Q" Infusion Set
NORFOLK MEDICAL
ClearView™MAX
In Commercial Distribution

  • M991NM82130A123 ()
  • M991NM82130A122 ()
  • M991NM82130A121 ()

  • Needle Gauge: 24 Gauge
NM82130A-12

  • Electric infusion pump administration set, single-use
24G x 6mm x 6" Clear-View MAX "Sub-Q" Infusion Set
NORFOLK MEDICAL
ClearView™MAX
In Commercial Distribution

  • M991NM82130A2 ()
  • M991NM82130A1 ()
  • M991NM82130A3 ()

  • Needle Gauge: 24 Gauge
NM82130A

  • Electric infusion pump administration set, single-use
Quala Mask Surgical Molded Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCPKA
In Commercial Distribution

  • D023GCPKA5 ()
  • D023GCPKA3 ()
  • D023GCPKA1 ()
GCPKA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Lavender
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCILVA
In Commercial Distribution

  • D023GCILVA50 ()
  • D023GCILVA3 ()
  • D023GCILVA1 ()
GCILVA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIBLA
In Commercial Distribution

  • D023GCIBLA5 ()
  • D023GCIBLA3 ()
  • D023GCIBLA1 ()
GCIBLA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Surgical Molded Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCBLA
In Commercial Distribution

  • D023GCBLA55 ()
  • D023GCBLA33 ()
  • D023GCBLA13 ()
GCBLA

  • Surgical/medical respirator, non-antimicrobial, single-use
The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system
SOLEIL LED SLEEVE 135 BX500
BENCO DENTAL SUPPLY CO.
5128-792
In Commercial Distribution

  • D74451287922 ()
  • D74451287921 ()
  • D74451287920 ()


  • Instrument/equipment drape, single-use, non-sterile
SOLEIL S1600 LED SLEEVES BX500
BENCO DENTAL SUPPLY CO.
5118-427
In Commercial Distribution

  • D74451184270 ()
  • D74451184271 ()
  • D74451184272 ()


  • Instrument/equipment drape, single-use, non-sterile
Monophase Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0030
In Commercial Distribution

  • D745701031CAP00171 ()
  • D745701031CAP00300 ()
  • D745701028CAP00121 ()
70-1031-CAP0030

  • Silicone dental impression material
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