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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Surgical N95 Respirator
LOUIS M. GERSON CO.
3230+
In Commercial Distribution

  • 00860006025762 ()
  • 00860006025793 ()
  • 00860006025779 ()
083230+

  • Surgical/medical respirator, non-antimicrobial, single-use
ACI’s Model 3120, light blue single use Surgical N95 Respirator is approved and cleared by NIOSH/FDA (TC-84A-9318), for use in healthcare settings. ACI’s Surgical N95 Respirator conforms to recognized standards for flammability, fluid resistance, and biocompatibility. Fluid resistance is a level 3, which is the highest level of protection (160 mm Hg).
Advanced Concept Innovations, LLC
3120
In Commercial Distribution

  • 00860005493227 ()
  • 00860005493203 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
ACI’s Model 3120, light blue single use Surgical N95 Respirator is approved and cleared by NIOSH/FDA (TC-84A-9318), for use in healthcare settings. ACI’s Surgical N95 Respirator conforms to recognized standards for flammability, fluid resistance, and biocompatibility. Fluid resistance is a level 3, which is the highest level of protection (160 mm Hg).
Advanced Concept Innovations, LLC
3120
In Commercial Distribution

  • 00860005493210 ()
  • 00860005493203 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
N95 Respirator Sample Pack
HU-FRIEDY MFG. CO., LLC
SP-GN95
Not in Commercial Distribution

  • 10889950133696 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
NIOSH approved and FDA cleared cone style N95 disposable respirator, adult small size.
DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.
9500-N95S
In Commercial Distribution

  • 06924997819114 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
NIOSH approved and FDA cleared duckbill style N95 disposable respirator, regular size.
DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.
910-N95FMX
In Commercial Distribution

  • 06924997809061 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size.
DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.
9500-N95
In Commercial Distribution

  • 06924997807876 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Honeywell DC365N95S Surgical N95 Respirator Mask w/ Nose clip, Small
Honeywell International Inc.
DC365N95HCS
In Commercial Distribution

  • 00883940422527 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Honeywell DF365N95HC Surgical N95 Respirator Mask w/ Nose clip
North Safety de Mexicali, S. de R. L. de C.V.
DF365N95HC
In Commercial Distribution

  • 00883940410425 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Honeywell DC370N95 Surgical N95 Respirator Mask w/ Nose clip
Honeywell International Inc.
DC370N95HC
In Commercial Distribution

  • 00883940401256 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
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