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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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Adventure Medical Kits - 00814471011362

CPR Shield One Way Valve, Box
Adventure Ready Brands
1
In Commercial Distribution

  • 00814471011362 ()
9999-1601

  • First aid kit, medicated

REAL Immersive System - 00815948024229

REAL i-Series
PENUMBRA, INC.
RLE1-A
In Commercial Distribution

  • 00815948024229 ()


  • Mental health/function therapeutic software, virtual reality
  • Mindfulness/behavioural therapy software, non-clinician-consultative

BioFire® Respiratory Panel 2.1 EUA - 00815381020482

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423738
Not in Commercial Distribution

  • 00815381020482 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests - 00815381020239

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Curaplex - 00815277028349

MEDICINAL KIT
BOUND TREE MEDICAL, LLC
1310-15203
In Commercial Distribution

  • 00815277028349 ()
1310-15203

  • First aid kit, medicated

CMATT - 00815073028253

CASCO FACE MASK
CASCO MANUFACTURING SOLUTIONS, INC.
P10001
In Commercial Distribution

  • 00815073028253 ()
P10001

  • Surgical/medical face mask, single-use

BinaxNOW COVID-19 Antigen Self Test - 00811877011798

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-241
In Commercial Distribution

  • 00811877011798 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

BinaxNOW COVID-19 Antigen Self Test - 00811877011736

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-280
In Commercial Distribution

  • 00811877011736 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

BinaxNOW COVID-19 Antigen Self Test - 00811877011712

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-269
In Commercial Distribution

  • 00811877011712 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

BinaxNOW COVID-19 Antigen Self Test - 00811877011705

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
Alere Scarborough, Inc.
195-268
In Commercial Distribution

  • 00811877011705 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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