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
ATOMO kn95 face mask, white, #1
ATOMO DENTAL, INC.
AA0839
In Commercial Distribution

  • D883AA08393 ()
  • D883AA08391 ()
  • D883AA08390 ()


  • Aerosol face mask, rebreathing, single-use
ATOMO kn95 face mask, white, #2
ATOMO DENTAL, INC.
AA0832
In Commercial Distribution

  • D883AA08323 ()
  • D883AA08321 ()
  • D883AA08320 ()


  • Aerosol face mask, rebreathing, single-use
Mini-fiber, high electrostatic filter, filtration efficiency of dust & powder above 95%. Continually repels contamination of blood and saliva. Inner cover sweat absorbant with water resistant outer cover. Low breathing resistance and high filtration efficiency.
I-Med Pharma Inc
5200
In Commercial Distribution

  • 00622554052016 ()
  • 00622554052009 ()
5200

  • Surgical/medical face mask, single-use
Mask intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer
I-Med Pharma Inc
5100
In Commercial Distribution

  • 00622554055017 ()
  • 00622554051002 ()
5100

  • Surgical/medical face mask, single-use
No Description
Dynarex Corporation
2296
In Commercial Distribution

  • 00616784229638 ()
  • 00616784229621 ()
  • 00616784229614 ()


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