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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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A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
190-000
Not in Commercial Distribution

  • 10811877011269 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Neumodx Molecular, Inc.
300800
In Commercial Distribution

  • 00814278021267 ()
  • 10814278021264 ()
300800

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
Hans Hepp GmbH & Co. KG
89115
Not in Commercial Distribution

  • 04007418891158 ()


  • Public face mask, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
Hans Hepp GmbH & Co. KG
89114
In Commercial Distribution

  • 04007418891141 ()


  • Public face mask, single-use
ARVA Lite Explorer
Adventure Ready Brands
1
In Commercial Distribution

  • 03700507909703 ()
2099-1000

  • First aid kit, medicated
Tin First Aid Kit Item#3556 Features: Retro tin case Small enough to store in a glove compartment, backpack, purse or bag Includes 4 latex-free bandages, 2 snip bandages, 2 antiseptic towelettes, 2 first aid cream packets, a hand sanitizer packet and a 2" x 3" adhesive pad
EVANS MANUFACTURING, INC.
3556
In Commercial Distribution

  • G40935560 ()
3556

  • First aid kit, medicated
Mini Sling First Aid Kit Item#3553 Features: Mini drawstring bag Includes 6 latex-free bandages, 2 antiseptic towelettes, a 2" x 3" adhesive pad, a first aid cream packet, and a hand sanitizer packet
EVANS MANUFACTURING, INC.
3553
In Commercial Distribution

  • G40935530 ()
3553

  • First aid kit, medicated
Clip-It™ First Aid Kit Item#3549 Features: 600D Polyester pouch with clip Includes 5 latex-free bandages, 2 snip bandages, 2 PAWS towelettes, 2 first aid cream packets, 2 hand sanitizer packets & a 2" x 3" adhesive pad
EVANS MANUFACTURING, INC.
3549
In Commercial Distribution

  • G40935490 ()
3549

  • First aid kit, medicated
Safescape First Aid Kit Item#3548 Features: Colorful, translucent vinyl pouch with clip Includes 4 latex-free bandages, 4 hand sanitizer packets, 2 snip bandages, a 2" x 3" adhesive pad and a first aid cream packet
EVANS MANUFACTURING, INC.
3548
In Commercial Distribution

  • G40935480 ()
3548

  • First aid kit, medicated
Comfort Care™ Outdoor Kit Item#3544 Features: Deluxe plastic case Includes 5 latex-free bandages, 2 snip bandages, 2 first aid cream packets, 1- 2" x 3" adhesive pads, 2 paws antimicrobial wipes, 2 antacid packets, 2 sunscreen, 2 lip balm packets, and 2 – 200 mg ibuprofen packets
EVANS MANUFACTURING, INC.
3544
In Commercial Distribution

  • G40935440 ()
3544

  • First aid kit, medicated
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