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 Class Implantable

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Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and Infrared (850nm), help to mitigate a variety of skin conditions. There are 48 LEDs to provide a treatment area of 26 square cm. Battery powered with a charger.
Medtek Lighting Corporation
7000C
In Commercial Distribution

  • B3437000C1 ()


  • Blue/red/infrared phototherapy lamp
LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using Infrared Light or Combo Red/Infrared Light to provide a feeling of General Wellness.
Medtek Lighting Corporation
Regen
In Commercial Distribution

  • B3437000A3 ()


  • Blue/red/infrared phototherapy lamp
Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1030
Not in Commercial Distribution

  • B350GSD0110300 ()
GSD01-1030

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1029
Not in Commercial Distribution

  • B350GSD0110290 ()
GSD01-1029

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1028
Not in Commercial Distribution

  • B350GSD0110280 ()
GSD01-1028

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M68984497010 ()
84-497

  • First aid kit, medicated
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M68984493010 ()
84-493

  • First aid kit, medicated
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M6898444601010 ()
84-446-01

  • First aid kit, medicated
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M68984443010 ()
84-443

  • First aid kit, medicated
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
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