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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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Mobile Aid Kit (EPMK-MAK), Advanced, Hard Case, Yellow - 00850018201575

The Emergency Preparedness Mobile Kit - Mobile Aid Kit Advanced is designed for those who have completed a Basic Life Support (BLS) course and/or are certified to diagnose and treat patients.
Altitude Technologies Inc.
01377HC
In Commercial Distribution

  • 00850018201575 ()
01377HC

  • First aid kit, medicated

Mobile Aid Kit (EPMK-MAK), Advanced, Bag, Red - 00850018201568

The Emergency Preparedness Mobile Kit - Mobile Aid Kit Advanced is designed for those who have completed a Basic Life Support (BLS) course and/or are certified to diagnose and treat patients.
Altitude Technologies Inc.
01377RD
In Commercial Distribution

  • 00850018201568 ()
01377RD

  • First aid kit, medicated

Mojo First Responder Bag - Intermediate Case of 5 - M6898330305010

Case of 5 for Mojo First Responder-Intermediate Your Mojo Medical Bag is equipped with MARCH Medical Gear featuring simple treatment icons and color-coding below: MASSIVE HEMORRAHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898330305010 ()
83-303-05

  • First aid kit, medicated

Rapid SARS-CoV-2 Antigen Test Card - 00855636003716

The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
LUMIQUICK DIAGNOSTICS, INC.
1N40C5-1-US-BS
In Commercial Distribution

  • 00855636003723 ()
  • 00855636003716 ()
  • 00855636003730 ()
  • 00855636003747 ()
  • 00855636003754 ()
  • 00855636003761 ()
  • 00855636003778 ()
  • 00855636003785 ()
1N40C5-1-US-BS

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

BinaxNOW COVID-19 Ag Card - 10811877011290

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

HPX Hyperpolarizer - 00850045949006

The HPX Hyperpolarizer is the device used to hyperpolarize the Xenon Xe 129 Gas Blend for the production of XENOVIEW™. It consists of a laser optical pumping system and a cryogenic xenon condenser system. With the use of the HPX Gas Handling Manifold, the Xenon Xe 129 Gas Blend is delivered to the HPX Hyperpolarizer where it undergoes spin exchange optical pumping (SEOP) process, which produces XENOVIEW™.
Polarean, Inc.
Rev E
In Commercial Distribution

  • 00850045949006 ()
49820

  • Lung MRI xenon hyperpolarization system

I-MED Nitrile Powder-Free and Latex-Free Gloves - 00622554050005

The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resistance as well as high virus protection. Enhanced tactile sensitivity allows for accurate work with smaller items.
I-Med Pharma Inc
5000
In Commercial Distribution

  • 00622554050012 ()
  • 00622554050005 ()
5000

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Traveler Kit (EPMK), Bleeding and CPR Basic - 00850018201605

The Emergency Preparedness Medical Kit -Traveler Kit, Bleeding and CPR Basic kit is a high-quality emergency items such as the SWAT-Tourniquet and a CPR face shield to address major life-threatening bleeding and cardiac arrest.
Altitude Technologies Inc.
01423BC
In Commercial Distribution

  • 00850018201605 ()
01423BC

  • First aid kit, medicated

TravelerPAK - 00850018892841

The TravelerPAK (Personal Aid Kit) is a medicated first aid kit to accommodate minor nicks, cuts, pain, and environmental exposures like sun burn, bug bites and other hazards that might happen during outside adventures.
Altitude Technologies Inc.
01484
In Commercial Distribution

  • 00850018892841 ()
01484

  • First aid kit, medicated

HPX Polarization Measurement Station - 00850045949020

The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.
Polarean, Inc.
Rev. D
In Commercial Distribution

  • 00850045949020 ()
42881

  • Lung MRI xenon hyperpolarization system
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