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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Fluid Resistant Surgical Tie Mask, High Filtration
PRESTIGE AMERITECH, LTD.
200601-04
In Commercial Distribution

  • 00852212003276 ()
  • 80852212003272 ()
  • 10852212003273 ()


  • Surgical/medical face mask, single-use
ProKids™ Child's Earloop Mask - Cook Children's Medical
PRESTIGE AMERITECH, LTD.
FM85030-CCM1
In Commercial Distribution

  • 10852212003266 ()
  • 00852212003269 ()
  • 80852212003265 ()


  • Surgical/medical face mask, single-use
Fluid Resistant Earloop Mask, High Filtration
PRESTIGE AMERITECH, LTD.
200601-01
In Commercial Distribution

  • 10852212003259 ()
  • 00852212003252 ()
  • 80852212003258 ()


  • 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
Imprints™ Customer Selected Custom Print, Tie (USA)
PRESTIGE AMERITECH, LTD.
FM85120
In Commercial Distribution

  • 20852212003232 ()
  • 00852212003238 ()
  • 80852212003234 ()


  • Surgical/medical face mask, single-use
Imprints™ Pediatric Mask, Crayon Print, Earloop (USA)
PRESTIGE AMERITECH, LTD.
FM85030
In Commercial Distribution

  • 00852212003214 ()
  • 80852212003210 ()
  • 20852212003218 ()


  • Surgical/medical face mask, single-use
Pro-80™ Fluid Resistant Procedure Mask 80mm, Earloop, Blue (USA)
PRESTIGE AMERITECH, LTD.
FM84010
In Commercial Distribution

  • 20852212003188 ()
  • 00852212003184 ()
  • 80852212003180 ()
  • 30852212003185 ()


  • Surgical/medical face mask, single-use
Dry Shield™ Fluid Resistant Mask 160mm, Tie, Anti-Glare/Anti-Fog Visor, Ice
PRESTIGE AMERITECH, LTD.
FM82120
In Commercial Distribution

  • 20852212003157 ()
  • 00852212003153 ()
  • 80852212003159 ()


  • Surgical/medical face mask, single-use
Dry Shield™ Fluid Resistant Mask 160mm, Tie w/o Visor, Ice Blue (USA)
PRESTIGE AMERITECH, LTD.
FM82110
In Commercial Distribution

  • 20852212003140 ()
  • 00852212003146 ()
  • 80852212003142 ()


  • Surgical/medical face mask, single-use
Dry Shield™ Fluid Resistant Mask 160mm, Earloop, Anti-Glare/Anti-Fog Visor,
PRESTIGE AMERITECH, LTD.
FM82020
In Commercial Distribution

  • 20852212003133 ()
  • 00852212003139 ()
  • 80852212003135 ()


  • Surgical/medical face mask, single-use
Dry Shield™ Fluid Resistant Mask 160mm, Earloop w/o Visor, Ice Blue (USA)
PRESTIGE AMERITECH, LTD.
FM82010
In Commercial Distribution

  • 20852212003126 ()
  • 00852212003122 ()
  • 80852212003128 ()


  • Surgical/medical face mask, single-use
Pro-Lite™ Surgical Mask, Tie, Blue (USA)
PRESTIGE AMERITECH, LTD.
FM81110
In Commercial Distribution

  • 20852212003119 ()
  • 00852212003115 ()
  • 80852212003111 ()


  • Surgical/medical face mask, single-use
ProGear™ Isolation Mask, Earloop, Green (USA)
PRESTIGE AMERITECH, LTD.
FM81030
In Commercial Distribution

  • 10852212003105 ()
  • 00852212003108 ()
  • 80852212003104 ()


  • Surgical/medical face mask, single-use
ProGear™ Procedure Mask, Earloop, Blue (USA)
PRESTIGE AMERITECH, LTD.
FM81020
In Commercial Distribution

  • 20852212003096 ()
  • 00852212003092 ()
  • 80852212003098 ()


  • Surgical/medical face mask, single-use
ProGear™ Isolation Mask, Earloop, Yellow, Economy (USA)
PRESTIGE AMERITECH, LTD.
FM81000
In Commercial Distribution

  • 00852212003085 ()
  • 80852212003081 ()
  • 20852212003089 ()


  • Surgical/medical face mask, single-use
Clear-View™ Anti-Fog Foam Strip Mask, Tie, Green (USA)
PRESTIGE AMERITECH, LTD.
FM80120
In Commercial Distribution

  • 20852212003072 ()
  • 00852212003078 ()
  • 80852212003074 ()


  • Surgical/medical face mask, single-use
Pro-80™ Duckbill Fluid Resistant Mask 80mm, Tie, Anti-Glare/Anti-Fog Visor,
PRESTIGE AMERITECH, LTD.
FM84320
In Commercial Distribution

  • 00852212003061 ()
  • 80852212003067 ()
  • 20852212003065 ()


  • Surgical/medical face mask, single-use
Pro-80™ Duckbill Fluid Resistant Mask 80mm, Tie, Blue (USA)
PRESTIGE AMERITECH, LTD.
FM84310
In Commercial Distribution

  • 10852212003051 ()
  • 00852212003054 ()
  • 80852212003050 ()


  • Surgical/medical face mask, single-use
Pro-80™ Horizontal Tie, Fluid Resistant Mask 80mm, Anti-Glare/Anti-Fog Viso
PRESTIGE AMERITECH, LTD.
FM84220
In Commercial Distribution

  • 20852212003041 ()
  • 00852212003047 ()
  • 80852212003043 ()


  • Surgical/medical face mask, single-use
Pro-80™ Horizontal Tie, Fluid Resistant Mask 80mm, Blue (USA)
PRESTIGE AMERITECH, LTD.
FM84210
In Commercial Distribution

  • 30852212003031 ()
  • 00852212003030 ()
  • 80852212003036 ()


  • Surgical/medical face mask, single-use
Clear-View™ Anti-Fog Tape Strip Mask, Tie, Green (USA)
PRESTIGE AMERITECH, LTD.
FM80110
In Commercial Distribution

  • 20852212003027 ()
  • 00852212003023 ()
  • 80852212003029 ()


  • Surgical/medical face mask, single-use
ProGear™ Isolation Mask, Earloop, Yellow (USA)
PRESTIGE AMERITECH, LTD.
FM81010
In Commercial Distribution

  • 20852212003010 ()
  • 00852212003016 ()
  • 80852212003012 ()


  • Surgical/medical face mask, single-use
Clear-View™ Anti-Fog Film Strip Mask, Tie, Green (USA)
PRESTIGE AMERITECH, LTD.
FM80130
In Commercial Distribution

  • 00852212003009 ()
  • 60852212003001 ()
  • 80852212003005 ()


  • Surgical/medical face mask, single-use
Dry Shield TM Fluid Resistant Mask 160 mm, Tie w/o Visor, Blue
PRESTIGE AMERITECH, LTD.
FM82130
In Commercial Distribution

  • 20852212003584 ()
  • 00852212003580 ()
  • 80852212003586 ()


  • Surgical/medical face mask, single-use
Earloop Mask with Ribbon Print
PRESTIGE AMERITECH, LTD.
FM85012
In Commercial Distribution

  • 00852212003573 ()
  • 80852212003579 ()


  • Surgical/medical face mask, single-use
Dry Shield TM Fluid Resistant Mask 160mm, Earloop w/o Visor, Blue
PRESTIGE AMERITECH, LTD.
FM82030
In Commercial Distribution

  • 20852212003539 ()
  • 00852212003535 ()
  • 80852212003531 ()


  • Surgical/medical face mask, single-use
Imprints™ Customer Selected Custom Print Mask, Earloop (USA)
PRESTIGE AMERITECH, LTD.
FM85010
In Commercial Distribution

  • 20852212003201 ()
  • 00852212003207 ()
  • 80852212003203 ()


  • Surgical/medical face mask, single-use
Pro-80™ Fluid Resistant Surgical Mask 80mm, Tie, Blue (USA)
PRESTIGE AMERITECH, LTD.
FM84110
In Commercial Distribution

  • 20852212003195 ()
  • 00852212003191 ()
  • 80852212003197 ()


  • Surgical/medical face mask, single-use
Skin-Saver™ Sensitive Skin Mask, Tie, White (USA)
PRESTIGE AMERITECH, LTD.
FM83110
In Commercial Distribution

  • 20852212003171 ()
  • 00852212003177 ()
  • 80852212003173 ()


  • Surgical/medical face mask, single-use
Skin-Saver™ Sensitive Skin Mask, Earloop, White (USA)
PRESTIGE AMERITECH, LTD.
FM83010
In Commercial Distribution

  • 20852212003164 ()
  • 00852212003160 ()
  • 80852212003166 ()


  • Surgical/medical face mask, single-use
Disposable Face Mask Level 1
Neil Medical Group
FM1010
In Commercial Distribution

  • 00850063139250 ()
  • 00850063139267 ()
  • 85006313926700 ()
FM1010

  • Surgical/medical face mask, non-antimicrobial, reusable
Surgical Mask LV2
Calico Medical Group LLC
SM002
In Commercial Distribution

  • 20850044458916 ()
  • 00850044458912 ()
  • 10850044458919 ()
SM002

  • Surgical/medical face mask, non-antimicrobial, single-use
Surgical Mask LV1
Calico Medical Group LLC
SM001
In Commercial Distribution

  • 20850044458909 ()
  • 00850044458905 ()
  • 10850044458902 ()
SM001

  • Surgical/medical face mask, non-antimicrobial, single-use
Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex.
Premier Guard Usa, LLC
20-1002-SFM3
In Commercial Distribution

  • 00850019294156 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.
Premier Guard Usa, LLC
20-1001-FM
In Commercial Distribution

  • 00850019294026 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs
Premier Guard Usa, LLC
20-1002-SFM3
In Commercial Distribution

  • 00850019294019 ()
  • 00850019294330 ()
  • 10850019294016 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs
Premier Guard Usa, LLC
20-1003-SFM2
In Commercial Distribution

  • 00850019294002 ()
  • 00850019294347 ()
  • 20850019294006 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 4-Ply Surgical Mask (Model:62232) Outer Case of 2,000 Masks
Altor Safety LLC
62232
In Commercial Distribution

62232

  • Surgical/medical face mask, non-antimicrobial, single-use
Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

62232

  • Surgical/medical face mask, non-antimicrobial, single-use
High Fluid Resistant Surgical Face Masks
United Sewing Automation, Inc.
U-325W
In Commercial Distribution

  • 00850018322003 ()
  • 00850018322126 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.
U.S. HEALTH EXPRESS CORP.
2082Blue
In Commercial Distribution

  • 00850017230026 ()
  • 00850017230002 ()
2082

  • Surgical/medical face mask, single-use
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
FE2311
Not in Commercial Distribution

  • 00850022724190 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
FE2311
Not in Commercial Distribution

  • 00850022724183 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level 3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
BYD Precision Manufacture Co., Ltd.
FE2311
In Commercial Distribution

  • 00850022724176 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level 3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
BYD Precision Manufacture Co., Ltd.
FE2311
In Commercial Distribution

  • 00850022724169 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating
Armbrust Inc.
850022550218
In Commercial Distribution

  • 00850022550218 ()
  • 00850022550256 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3
Armbrust Inc.
850022550003
In Commercial Distribution

  • 00850022550003 ()
  • 00850022550010 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
PrimaPro GentleWare ASTM Level 3 Face Mask, Blue, 4 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
B183028EL
In Commercial Distribution

  • 10850022371506 ()
  • 00850022371509 ()
  • 20850022371503 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
B182028EL
In Commercial Distribution

  • 10850022371490 ()
  • 00850022371493 ()
  • 20850022371497 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Bag, 20 Bags/Case, 1,000 Masks/Case, Single Use
PRIMARY PRODUCTS COMPANY
W182028EL-BG
In Commercial Distribution

  • 10850022371483 ()
  • 00850022371486 ()
  • 20850022371480 ()


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