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
Single-use Face Mask Soft & Easy to Breath Use as Surgical Mask
BYD Precision Manufacture Co., Ltd.
FF1311
In Commercial Distribution

  • 00860003624807 ()

  • Area/Surface Area: 25.77 Square inch
FF1311

  • Surgical/examination garment kit
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
Disposable Face Mask
Shenzhen 3Nod Electronics Co., Ltd.
14cm*9cm
In Commercial Distribution

  • 06922634100076 ()
  • 06922634100083 ()


  • Surgical/medical face mask, single-use
Disposable Face Mask
Shenzhen 3Nod Electronics Co., Ltd.
17.5cm*9.5cm
In Commercial Distribution

  • 06922634100069 ()
  • 06922634100090 ()


  • Surgical/medical face mask, single-use
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