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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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The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution

  • 15099590742768 ()
C69059

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69057
In Commercial Distribution

  • 15099590742744 ()
C69057

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Emergency Preparedness Medical Kit -Expedition (EPMK) – Expedition Kit is intended for larger groups and contains all the necessary supplies to treat a wide variety of injuries associated with backcountry emergencies such as severe bleeding, bone fractures, extended would management, blister care, dental care, and hypothermia management.
Altitude Technologies Inc.
01390RD
In Commercial Distribution

  • 00850018201513 ()
01390RD

  • First aid kit, medicated
The Emergency Preparedness Medical Kit -Expedition (EPMK) – Expedition Kit is intended for larger groups and contains all the necessary supplies to treat a wide variety of injuries associated with backcountry emergencies such as severe bleeding, bone fractures, extended would management, blister care, dental care, and hypothermia management.
Altitude Technologies Inc.
01390HC
In Commercial Distribution

  • 00850018201506 ()
01390HC

  • First aid kit, medicated
Ripstop First Aid Kit Item#3550 Features: 3 1/2" x 5" pouch constructed of 210D polyester ripstop material with clip Includes 4 latex-free bandages, 2 snip bandages, 2 antiseptic towelettes, 2 first aid cream packets, a hand sanitizer packet and a 2" x 3" adhesive pad
EVANS MANUFACTURING, INC.
3550
In Commercial Distribution

  • G40935500 ()
3550

  • First aid kit, medicated
Upgrade to the Adventurer + Bleeding & CPR Basic Kit with high-quality emergency items such as the SWAT-Tourniquet and a CPR face shield to address major life-threatening bleeding and cardiac arrest. The Bleeding & CPR Basic Kit comes inside the Minimalist Bag and is designed to attach to the inside of the Adventurer Kit.
Altitude Technologies Inc.
01424BC
In Commercial Distribution

  • 00850018201414 ()
01424BC

  • First aid kit, medicated
Roll-It™ First Aid Kit Item#3527 Features: Constructed of ripstop material Features a roll top dry sack style design Black buckle closure with carabiner attachment Includes 6 latex-free bandages, 2 snip bandages, 2 antiseptic towelettes, 2 first aid cream packets, a hand sanitizer packet and a 2" x 3" adhesive pad
EVANS MANUFACTURING, INC.
3527
In Commercial Distribution

  • G40935270 ()
3527

  • First aid kit, medicated
We Care First Aid Kit Item#3538 Features: Zippered pouch is constructed of 210D polyester with PU backing Colorful pattern on top extends to the entire backside Includes 5 latex-free bandages, 2 snip bandages, 2 first aid cream packets, 2 antiseptic towelettes, 1 hand sanitizer packet, 2" x 3" adhesive pad & 1 Ibuprofen packet
EVANS MANUFACTURING, INC.
3538
In Commercial Distribution

  • G40935380 ()
3538

  • First aid kit, medicated
Heathered First Aid Kit Item#3528 Features: Constructed of 300D heathered grey polyester Features a color zippered accent Use split ring attachment to hang from bags, keyring, etc. Includes 4 latex-free bandages, 2 snip bandages, 2 first aid cream packets, a PAWS towelette, a 200 mg Ibuprofen packet & a 2" x 3" adhesive pad
EVANS MANUFACTURING, INC.
3528
In Commercial Distribution

  • G40935280 ()
3528

  • First aid kit, medicated
A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
NANOVIBRONIX INC.
3.0 Actuator
In Commercial Distribution

  • 07290103420123 ()
10-200-0002

  • Urinary catheter ultrasonic bacterial adhesion inhibition system actuator
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