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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ABSORBENT COMPRESS, ALCOHOL PREP PAD, ANTACID (2/PACKAGE), ANTIBIOTIC OINTMENT, ANTISEPTIC TOWELETTE, ASPIRIN (2/PACKAGE), BURN CREAM, COTTON SWABS, CPR MASK, ELASTIC BANDAGE, EXTRA-STRENGTH ACETAMINOPHEN (2/PACKAGE), EYE PAD WITH TAPE, FABRIC BANDAGE, FABRIC FINGERTIP BANDAGE, FABRIC KNUCKLE BANDAGE, FIRST AID FACTS GUIDE, FIRST AID TAPE , PLASTIC TWEEZERS, GAUZE PAD - 2 X 2", GAUZE PAD - 3 X 3", GAUZE ROLL, IBUPROFEN (2/PACKAGE), INSTANT ICE PACK, NITRILE GLOVE, NON-STICK PADS, PLASTIC BANDAGE, SCISSORS, SINGLE USE SALINE, SINUS AND CONGESTION (2/PACKAGE), STING WIPES, TRIANGULAR BANDAGE
ULINE, INC.
H-3319
In Commercial Distribution

  • 10851253007622 ()
H-3319

  • First aid kit, medicated
ABSORBENT COMPRESS, ALCOHOL PREP PAD, ANTIBIOTIC OINTMENT, ANTISEPTIC TOWELETTE, ASPIRIN (2/PACKAGE), BURN CREAM, CPR MASK, ELASTIC BANDAGE, EYE PAD, FABRIC BANDAGE, FABRIC FINGERTIP BANDAGE, FABRIC KNUCKLE BANDAGE, FIRST AID FACTS GUIDE , FIRST AID TAPE, PLASTIC TWEEZERS, GAUZE PAD, GAUZE ROLL, INSTANT ICE PACK, NITRILE GLOVE, NON-STICK PADS, PLASTIC BANDAGE, SCISSORS, SINGLE USE SALINE, STING WIPES, TRIANGULAR BANDAGE
ULINE, INC.
H-1294
In Commercial Distribution

  • 10851253007615 ()
H-1294

  • First aid kit, medicated
ABSORBENT COMPRESS, ANTIBIOTIC OINTMENT, ANTISEPTIC TOWELETTE, ASPIRIN (2/PACKAGE), BURN CREAM, CPR MASK, EYE PAD, FABRIC BANDAGE, FABRIC FINGERTIP BANDAGE, FABRIC KNUCKLE BANDAGE, FIRST AID FACTS GUIDE, FIRST AID TAPE, PLASTIC TWEEZERS, GAUZE PAD, GAUZE ROLL, INSTANT ICE PACK, NITRILE GLOVE, PLASTIC BANDAGE, SCISSORS, SINGLE USE SALINE, TRIANGULAR BANDAGE
ULINE, INC.
H-1293
In Commercial Distribution

  • 10851253007608 ()
H-1293

  • First aid kit, medicated
ABSORBENT COMPRESS, ANTIBIOTIC OINTMENT, ANTISEPTIC TOWELETTE, BURN CREAM, FABRIC FINGERTIP BANDAGE, FABRIC KNUCKLE BANDAGE, FIRST AID FACTS GUIDE, FIRST AID TAPE, PLASTIC TWEEZERS, GAUZE PAD, GAUZE ROLL, INSTANT ICE PACK, NITRILE GLOVE, PLASTIC BANDAGE, SCISSORS, TRIANGULAR BANDAGE
ULINE, INC.
H-1292
In Commercial Distribution

  • 10851253007592 ()
H-1292

  • First aid kit, medicated
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
Alere Scarborough, Inc.
195-200
In Commercial Distribution

  • 10811877011337 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Control swabs intended for use only with BinaxNOW COVID-19 Ag product manufactured by Abbott Diagnostics Scarborough, Inc.
Alere Scarborough, Inc.
195-080
In Commercial Distribution

  • 10811877011306 ()


  • SARS-CoV-2 antigen IVD, control
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider.
Alere Scarborough, Inc.
195-000
In Commercial Distribution

  • 10811877011290 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs
Alere Scarborough, Inc.
190-080
Not in Commercial Distribution

  • 10811877011276 ()


  • SARS-CoV-2 nucleic acid IVD, control
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)
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
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