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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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Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAG025-NU
In Commercial Distribution

  • 08800076700499 ()
  • 08800076700482 ()
COVAG025-NU

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.
Genbody Inc.
COVAG025-U
In Commercial Distribution

  • 08800076700437 ()
  • 08800076700475 ()
COVAG025-U

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-2
In Commercial Distribution

  • 08800076700741 ()
  • 08800076700222 ()
COVAGHT2-U-02

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
AEMT KIT SWAT-T Tourniquet 1 ea Celox Rapid 1 ea Duct Tape 1 ea
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M6898811201010 ()
88-112-01

  • First aid kit, non-medicated, single-use
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
Mojo Medical Bags are equipped with MARCH Medical Gear in our simplified, color-coded treatment system linking icon identifiers to a treatment category within the MARCH protocol. MASSIVE HEMORRHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M68983303040 ()
83-303

  • First aid kit, medicated
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