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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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
ProGear™ N95 Surgical Mask Respirator, Regular, Fluid Resistant 160mm, Whit
PRESTIGE AMERITECH, LTD.
RP88020
In Commercial Distribution

  • 10852212003327 ()
  • 00852212003320 ()
  • 80852212003326 ()


  • Surgical/medical face mask, single-use
ProGear™ N95 Surgical Mask Respirator, Small, Fluid Resistant 160mm, White
PRESTIGE AMERITECH, LTD.
RP88010
In Commercial Distribution

  • 10852212003310 ()
  • 00852212003313 ()
  • 80852212003319 ()


  • Surgical/medical face mask, single-use
Ported N95 Particulate Filter Respirator
PRESTIGE AMERITECH, LTD.
RP88520
In Commercial Distribution

  • 10852212003242 ()
  • 00852212003245 ()
  • 80852212003241 ()


  • Surgical/medical face mask, single-use
N95 RESP MASK UNIVERSAL
Trinity Sterile, Inc.
2313
In Commercial Distribution

  • 00841767106037 ()
  • 10841767106034 ()


  • Public face mask, single-use
No Description
YOUNG MYDENT, LLC
MK-N95
In Commercial Distribution

  • 00816577022259 ()


  • Surgical/medical face mask, single-use
Facemask, N95 Particulate Respirator, Small
MYCO MEDICAL SUPPLIES INC.
MYTN01-12
In Commercial Distribution

  • 20386120010858 ()
  • 10386120010851 ()
  • 00386120010854 ()
MYTN01-12

  • Surgical/medical face mask, single-use
Facemask, N95 Particulate Respirator, Medium
MYCO MEDICAL SUPPLIES INC.
MYTN01-11
In Commercial Distribution

  • 20386120010841 ()
  • 10386120010844 ()
  • 00386120010847 ()
MYTN01-11

  • Surgical/medical face mask, single-use
CareMates 3ct N-95 (Flat Fold) NIOSH Masks
Shepard Medical Products, Inc.
03710420
In Commercial Distribution

  • 00715912037104 ()
  • 10715912037101 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
CareMates 10ct N-95 Masks
Shepard Medical Products, Inc.
017106201
In Commercial Distribution

  • 00715912017106 ()
  • 10715912017103 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
4150
In Commercial Distribution

  • 50092311415005 ()
  • 00092311415000 ()
  • 10092311415007 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
1712 N95
In Commercial Distribution

  • 50092311171208 ()
  • 00092311171203 ()
  • 10092311171200 ()

  • Low Profile


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
1517 N95
In Commercial Distribution

  • 5092311151705 ()
  • 00092311151700 ()
  • 10092311151707 ()

  • Low Profile


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
1513 N95
In Commercial Distribution

  • 00092311151304 ()
  • 50092311151309 ()
  • 10092311151301 ()

  • Large


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
1512 N95
In Commercial Distribution

  • 50092311151200 ()
  • 00092311151205 ()
  • 10092311151202 ()

  • Medium


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
1511 N95
In Commercial Distribution

  • 50092311151101 ()
  • 00092311151106 ()
  • 10092311151103 ()

  • Small


  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
MOLDEX-METRIC, INC.
1510 N95
In Commercial Distribution

  • 00092311151007 ()
  • 10092311151004 ()
  • 50092311151002 ()

  • Extra-Small


  • Surgical/medical respirator, non-antimicrobial, single-use
American Red Cross Deluxe Personal Safety Emergency Pack - BZK Antiseptic Towelettes (2); Durable Nylon Backpack; Emergency Blanket; Emergency Drinking Water; Emergency Poncho; Fabric Bandage, 0.75" x 3" (3); Fingertip fabric bandage; Germicidal Wipes (2); Hand Warmers (2); Handsanitizer Pack; Knuckle Fabric Bandage; Light Stick; N95 mask; Nitrile Exam Gloves (2); Plastic Bandage, 0.75" x 3" (5); Plastic Bandage, 3/8" x 1.5" (5); Triple Antibiotic Ointment pack; Whistle.
Acme United Corporation
RC-622
In Commercial Distribution

  • 00092265726221 ()
RC-622

  • First aid kit, medicated
American Red Cross Deluxe Personal Safety Emergency Pack - Contains: BZK Antiseptic wipes (2); Emergency Blanket; Emergency Drinking Water; Emergency Poncho; Fabric Bandage, 0.75 x 3" (3); Fingertip fabric bandage; First Aid Cream; Germicidal Wipes (2); Hand sanitizer pack; Hand Warmers (2); Knuckle Fabric Bandage; Light Stick; N95 Mask; Nitrile Exam Gloves (2); Plastic Bandage, 0.75" x 3" (5); Plastic Bandage, 3/8" x 1.5" (5); Triple Antibiotic Ointment pack; Whistle
Acme United Corporation
RC-613
In Commercial Distribution

  • 00092265726139 ()
RC-613

  • First aid kit, medicated
Surgical Respirator
CROSSTEX INTERNATIONAL, INC.
GDBRESP
In Commercial Distribution

  • 50732224004919 ()
  • 10732224004911 ()
  • 00732224004914 ()
GDBRESP

  • Surgical/medical respirator, non-antimicrobial, single-use
Surgical Respirator
CROSSTEX INTERNATIONAL, INC.
GMLRESP
In Commercial Distribution

  • 50732224004698 ()
  • 10732224004690 ()
  • 00732224004693 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Isolator Plus N95 Mask
CROSSTEX INTERNATIONAL, INC.
GPRN95
Not in Commercial Distribution

  • D682GPRN9525 ()
  • 10732224000524 ()
  • 00732224000527 ()
GPRN95

  • Surgical/medical respirator, non-antimicrobial, single-use
VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gramnegative bacilli
BIOMERIEUX , INC.
VITEK® 2 AST-GN95
In Commercial Distribution

  • 03573026565923 ()
  • 03573026563844 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
LDR N95 Masks 5 ea
Cardinal Health 110, Inc.
5512934
In Commercial Distribution

  • 50096295137380 ()
  • 00096295137385 ()
  • 10096295137382 ()
5512934

  • Public respirator, single-use
N95 Resp w/Exhal Valve,Individ Pkgd,Flat Fold PK20 (1 box)
MARKETLAB INC.
21597
In Commercial Distribution

  • 00817517020199 ()
  • 00817517021059 ()
21597

  • Surgical/medical face mask, single-use
N95 Respirators,Individually Pkgd,Flat Fold PK20 (1box)
MARKETLAB INC.
21596
In Commercial Distribution

  • 00817517020182 ()
  • 00817517021042 ()
21596

  • Surgical/medical face mask, single-use
No Description
FGX INTERNATIONAL INC.
ASTSN95.ALB
In Commercial Distribution

  • 00031568152818 ()


  • Tinted non-prescription spectacles
3M™ Health Care Particulate Respirator and Surgical Mask 1860S, Small, N95, 120 EA/Case, Restricted
3M Company
1860S
In Commercial Distribution

  • 50068060858127 ()
  • 00068060858122 ()
  • 00076308401870 ()
1860S

  • Surgical/medical respirator, non-antimicrobial, single-use
No Description
FGX INTERNATIONAL INC.
ASTSN95.ALB
In Commercial Distribution

  • 00070135152813 ()


  • Tinted non-prescription spectacles
1730 Type N95 Particulate Respirator and Surgical Respirator
LOUIS M. GERSON CO.
1730
In Commercial Distribution

  • 00044585917308 ()
  • 00044585817301 ()
  • 50044585917303 ()
081730

  • Surgical/medical respirator, non-antimicrobial, single-use
Surgical N95 Respirator
LOUIS M. GERSON CO.
3330+
In Commercial Distribution

  • 00044585833301 ()
  • 00044585333016 ()
  • 50044585333011 ()
083330+

  • Surgical/medical respirator, non-antimicrobial, single-use
1860S HEALTH CARE RESPIRATOR N95 120EA/C
3M Company
1860S
In Commercial Distribution

  • 50051131275541 ()
  • 00051131275546 ()
  • 00051131272705 ()
1860S

  • Surgical/medical respirator, non-antimicrobial, single-use
1860 HEALTH CARE N95 MASK, 20EACH/BOX 6 BX/C
3M Company
1860
In Commercial Distribution

  • 50051131275534 ()
  • 00051131275539 ()
  • 00051131272699 ()
1860

  • Surgical/medical respirator, non-antimicrobial, single-use
N95 Particulate Filter Respirator and Surgical Mask
KIMBERLY-CLARK GLOBAL SALES, LLC
62355
In Commercial Distribution

  • 00036000623550 ()
  • 90036000623553 ()
  • 10036000623557 ()


  • Surgical/medical face mask, single-use
N95 Particulate Filter Respirator and Surgical Mask
KIMBERLY-CLARK GLOBAL SALES, LLC
62126
In Commercial Distribution

  • 00036000621266 ()
  • 90036000621269 ()
  • 10036000621263 ()


  • Surgical/medical face mask, single-use
N95 Particulate Filter Respirator and Surgical Mask
KIMBERLY-CLARK GLOBAL SALES, LLC
46867
In Commercial Distribution

  • 00036000468670 ()
  • 90036000468673 ()
  • 10036000468677 ()


  • Surgical/medical face mask, single-use
N95 Particulate Filter Respirator and Surgical Mask
KIMBERLY-CLARK GLOBAL SALES, LLC
46827
In Commercial Distribution

  • 00036000468274 ()
  • 90036000468277 ()
  • 10036000468271 ()


  • Surgical/medical face mask, single-use
N95 Particulate Filter Respirator and Surgical Mask
KIMBERLY-CLARK GLOBAL SALES, LLC
46767
In Commercial Distribution

  • 00036000467673 ()
  • 90036000467676 ()
  • 10036000467670 ()


  • Surgical/medical face mask, single-use
N95 Particulate Filter Respirator and Surgical Mask
KIMBERLY-CLARK GLOBAL SALES, LLC
46727
In Commercial Distribution

  • 00036000467277 ()
  • 90036000467270 ()
  • 10036000467274 ()


  • Surgical/medical face mask, single-use
N95 SURGICAL RESPIRATOR MASK 2CT
RITE AID CORPORATION
F405-604RA
In Commercial Distribution

  • 40011822257150 ()
  • 00011822257152 ()
  • 20011822257156 ()
  • 10011822257159 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
SAFEMASK N95 CONE RESPIRATOR EARLOOP WHITE
AMD Medicom Inc
M2321
Not in Commercial Distribution

  • 20686864033763 ()
  • 10686864033766 ()
  • 00686864033769 ()
M2321

  • Surgical/medical respirator, non-antimicrobial, single-use
SAFEMASK N95 DUCKBILL RESPIRATOR EARLOOP WHITE
AMD Medicom Inc
M2322
Not in Commercial Distribution

  • 20686864028493 ()
  • 10686864028496 ()
  • 00686864028499 ()
M2322

  • Surgical/medical respirator, non-antimicrobial, single-use
N-95 DUCKBILL RESPIRATOR MASK
AMD Medicom Inc
A2320
Not in Commercial Distribution

  • 10686864025112 ()
  • 10686864025150 ()
  • 20686864025157 ()
A2320

  • Surgical/medical respirator, non-antimicrobial, single-use
Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Large
AMD Medicom Inc
203414
In Commercial Distribution

  • 20686864056922 ()
  • 10686864056925 ()
  • 00686864056928 ()
203414

  • Surgical/medical respirator, non-antimicrobial, single-use
Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Medium
AMD Medicom Inc
203314
In Commercial Distribution

  • 20686864056915 ()
  • 10686864056918 ()
  • 00686864056911 ()
203314

  • Surgical/medical respirator, non-antimicrobial, single-use
Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Small
AMD Medicom Inc
203214
In Commercial Distribution

  • 20686864056908 ()
  • 10686864056901 ()
  • 00686864056904 ()
203214

  • Surgical/medical respirator, non-antimicrobial, single-use
3M™ Health Care Particulate Respirator and Surgical Mask 1860, N95, 120 EA/Case, Restricted
3M Company
1860
In Commercial Distribution

  • 50068060856963 ()
  • 00068060856968 ()
  • 00076308401863 ()
1860

  • Surgical/medical respirator, non-antimicrobial, single-use
DK N95 Mask Cone w/ 1way valve
Dukal LLC
1572
Not in Commercial Distribution

  • 10665973005772 ()
  • 00665973005775 ()
  • 20665973005779 ()
1572

  • Surgical/medical respirator, non-antimicrobial, single-use
DK N95 Mask, Cone, White
Dukal LLC
1571
Not in Commercial Distribution

  • 10665973005598 ()
  • 00665973005591 ()
  • 20665973005595 ()
1571

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